Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs, 51811-51819 [2015-21108]
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Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices
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[FR Doc. 2015–21189 Filed 8–25–15; 8:45 am]
BILLING CODE 6820–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Reporting of Pregnancy Success Rates
From Assisted Reproductive
Technology (ART) Programs
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (DHHS).
ACTION: Final notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) in the
Department of Health and Human
Services (HHS) announces the
requirements for reporting of pregnancy
success rates from assisted reproductive
technology (ART) programs as required
by the Fertility Clinic Success Rate and
Certification Act of 1992 (FCSRCA).
This notice describes who shall report
to HHS/CDC, the reporting system
(National ART Surveillance System
(NASS); the process for reporting by
each ART program; the data to be
SUMMARY:
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reported; and the contents of the
published reports. The proposed
changes to reporting requirements were
published in the Federal Register on
July 21, 2014 (79 FR. 42328) and
February 18, 2015 (80 FR. 8659) in
accordance with requirements under the
Paperwork Reduction Act; public
comments and recommendations were
requested. This notice incorporates the
comments received from those notices
and supersedes the previous notice
published in the Federal Register,
September 1, 2000 (65 FR. 53310).
FOR FURTHER INFORMATION CONTACT:
Jeani Chang, Division of Reproductive
Health, National Center for Chronic
Disease Prevention and Health
Promotion, Centers for Disease Control
and Prevention, 4770 Buford Highway,
MS–74, Atlanta, Georgia 30341. Phone:
(770) 488–6370. Email: artinfo@cdc.gov.
SUPPLEMENTARY INFORMATION: Section
2(a) of Public Law 102–493 (42
U.S.C.263a–1(a)), the Fertility Clinic
Success Rate and Certification Act of
1992 (FCSRCA) requires that each ART
program report annually to the Secretary
of the Department of Health and Human
Services through the Centers for Disease
Control and Prevention (1) pregnancy
success rates achieved by such ART
program and (2) the identity of each
embryo laboratory used by such ART
program and whether the laboratory is
certified or has applied for such
certification under the act.
FCSRCA defines ‘‘assisted
reproductive technology’’ (ART) as ‘‘all
treatments or procedures which include
the handling of human oocytes or
embryos, including in vitro fertilization,
gamete intrafallopian transfer, zygote
intrafallopian transfer, and such other
specific technologies as the Secretary
may include in this definition, after
making public any proposed definition
in such manner as to facilitate comment
from any person (including any federal
or other public agency).’’
The Secretary is directed in FCSRCA
to define pregnancy success rates and
‘‘make public any proposed definition
in such a manner as to facilitate
comment from any person during its
development.’’
Section 2(c) (42 U.S.C. 263a–1(c))
states ‘‘the Secretary shall consult with
appropriate consumer and professional
organizations with expertise in using,
providing, and evaluating professional
services and embryo laboratories
associated with assisted reproductive
technologies.’’
Since 1995, HHS/CDC has reported
pregnancy success rates of United States
ART programs as required by FCSRCA.
Changes in ART practice require
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periodic revision of the National ART
Surveillance System in order to
maintain accurate reporting of ART
success rates. In updating the
definitions of success rates, as well as
various factors and characteristics
required for calculating the success rates
or that might influence the success
rates, HHS/CDC consulted with
representatives of the Society for
Assisted Reproductive Technology
(SART, a national professional
association of ART clinical programs),
the American Society for Reproductive
Medicine (ASRM, a national society
dedicated to the advancement of the
science and practice of reproductive
medicine), RESOLVE (the National
Infertility Association, a national,
nonprofit consumer organization),
Path2Parenthood (P2P, a national,
nonprofit consumer organization), and
the American Urological Association
(AUA, a national professional
association of urologic community) as
well as a variety of individuals with
expertise and interest in infertility and/
or ART.
Public Comment Summary and
Responses
Seven comments were received in
response to the July 21, 2014 (79 FR.
42328) notice that outlined the reporting
requirements, changes to NASS data
elements, and the associated burden.
Comments are summarized by the
following topics: burden estimates,
proposed NASS data elements,
duplicative data collection, and request
for additional data elements. Some
commenters provide comments on
multiple topics. Summaries of these
comments, as well as HHS/CDC’s
responses, are provided below.
1. Burden estimates: Four commenters
expressed concern that implementation
of the new NASS system was not
included in the total burden estimates,
thus the burden to clinics for data
reporting was underestimated.
Response: The estimated annual
burden to clinics is calculated using the
average time required to answer the
number of questions and possible
responses to each question when
applicable. We acknowledge that there
is an additional burden for the first year
of this transition associated with making
the appropriate software modifications
that was not represented in the notice
published on July 21, 2014. In order to
minimize the impact of this burden on
clinic operations, projected
implementation of the new data
collection system was changed from
January 1, 2015 to January 1, 2016. We
have also recalculated the burden for
the first year to include the fixed burden
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associated with changes to the data
collection systems in each clinic. The
following changes were made to the
burden estimate: a) increased the
average burden to 43 minutes per
response and b) added a one-time
system implementation for each clinic
(40 hours per each response) to update
their data collection systems to reflect
the new platform and interface of the
NASS web-application over a 3-year
clearance period.
2. Proposed NASS data elements:
There was concern from one commenter
that the proposed data elements went
beyond the mandate established by
FCSRCA and its implementing
regulations. Commenter cited the
information related to the quality of any
embryo considered for transfer and prior
ART cycles that resulted in pregnancy
as two examples that appear to go
beyond the mandate.
Response: HHS/CDC thanks the
commenter for this comment, but notes
that changes to the NASS data elements
are essential to keep pace with changes
in medical practice, ensure that reported
success rates reflect standardized
definitions, and provide additional
insight into factors that may affect
success rates. Regarding the addition of
variables such as embryo quality and
the number of prior ART cycles, the
NASS system collects information on
ART outcomes as well as other patient
and procedure characteristics that may
affect treatment outcomes. The reporting
of success rates by patient and
procedural factors allows consumers to
see success rates for patients similar to
themselves and undergoing procedures
with similar characteristics. Presenting
success rates without taking patient and
procedural characteristics into account
could produce inaccurate rates.
3. Duplicative data collection: There
was concern from one commenter that
the collection of ART outcomes by
HHS/CDC duplicates the work SART
already does and the resulting cost of a
duplicative data collection to the
government and taxpayers is not
warranted.
Response: HHS/CDC notes the
commenter’s concern and reminds the
commenter that this data collection is
mandated by statute while data
collection by a private entity is not
required by law. FCSRCA requires that
each assisted reproductive technology
(ART) program annually report
pregnancy success rates achieved by
such ART program to the Secretary
through HHS/CDC. Changes in ART
practice require periodic revision of the
National ART Surveillance System in
order to maintain accurate reporting of
ART success rates.
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4. Request for additional data
elements: Three commenters suggested
the addition of data elements.
Commenter 1 suggested that it would
be important for the NASS and Assisted
Reproductive Technology Team to
consider adding variables relating to
infant outcomes (as listed below).
(1) Use of traditional or gestational
surrogate carriers: Surrogate age,
number of prior pregnancies, number of
previous live born infants, and number
of prior surrogacy (either gestational
carrier or traditional surrogate).
(2) Maternal variables: occurrence of
pregnancy induced hypertension,
maternal diabetes and stage,
hyperemesis gravidarium, fetal
ultrasound results with special focus on
fetal echocardiogram at 20–24 weeks.
(3) Placental examination: placental
abnormalities, evidence of single
umbilical artery, histologic
chorioamnionitis, in twins or multiple
gestations presence of twin to twin
transfusion syndrome associated with
artery-venous shunting in the placenta,
placentation (diamniontic-dichorionic,
monochorionic-diamniontic, and
placentation of greater than twin).
(4) Neonatal Variables Suggested to be
added:
A. Infant Weight, Length, and Head
Circumference
B. Infant Gestational age as
determined by Ballard Physical and
Neurodevelopment examination
C. Admission to Neonatal Intensive
Care Unit
D. Specific Neonatal Variables:
1. Apgar Scores as 1 and 5 minutes,
requirement for resuscitation,
2. NICU admission,
3. Length of Hospital Stay,
4. Time (in days) to regain birth
weight,
5. Specific Neonatal Morbidities:
a. Occurrence of Respiratory Distress
Syndrome,
b. Presence of patent ductus
arterioles,
c. Hyperbilirubinemia requiring A)
phototherapy and/or B)exchange
transfusion and maximum total
serum bilirubin,
d. Occurrence of intraventricular
hemorrhages by grade (Papille)i.e.
Grade I to IV,
e. Occurrence of periventricular
leukomalacia,
f. Occurrence of necrotizing
enterocolitis using the Bell scoring
system,
g. Occurrence of electrographic
seizures,
h. Did the infant pass the newborn
hearing screen,
i. Abnormalities on the Newborn
Metabolic Screen,
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j. Results of the screen for congenital
heart disease (Upper and Lower
Sp02 after 24 hours),
k. Occurrence of minor and major
phenotypic anomalies, occurrence
of specific syndromes including
imprinting disorders,
l. Karyotype results (if performed),
results of chromosomal arrays (if
performed).
Response: FCSRCA requires that each
assisted reproductive technology (ART)
program annually report pregnancy
success rates achieved by such ART
program to the Secretary through HHS/
CDC. Many of the suggested data
elements are only available through
vital records (i.e. birth certificates, fetal
death certificates) and NASS does not
collect information from birth
certificates. Collection of the additional
variables suggested is not feasible as
part of this effort. No changes to the data
collection were made as a result of this
comment.
Commenter 2 requested clarification if
the following male infertility data points
are included in the new planned data
collection:
• Medical condition
• Genetic or chromosomal abnormality,
Specifyllllll
• Abnormal sperm parameters (select
all that apply)
Azoospermia, obstructive
Azoospermia, non-obstructive
Oligospermia, severe (<5 million/mL)
Oligospermia, moderate (5–15
million/mL)
Low motility (<40%)
Low morphology (4%)
• Other male factor (not included
above), Specifyllllll
Response: The suggested male
infertility data points are already in the
proposed NASS data elements; thus, no
changes were made to the data
collection as a result of this comment.
Commenter 3 recommended adding
the method of delivery (Vaginal or Csection): Indication for c-section (if csection used) (Prior c-section, Overdue
delivery, Medical complication, Nonmedical indication/Patient preference).
This will take less than two additional
minutes per cycle with live birth (zero
for cycles without birth), as this
information is almost always in the
documents we routinely obtain.
Rationale for inclusion of this
information includes: Some reports
indicate c-section delivery is more
common with frozen-thawed embryo
transfer. It is also reported that frozenthawed embryo transfer is associated
with larger birthweights. These two
variables might be causally related, or
might be confounded in assessments of
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perinatal outcomes. Consider that large
infants can motivate a c-section, FET
cycles often follow a fresh delivery that
might have used a c-section and thus
create an indication for c-section, and csections abbreviate a pregnancy so that
birth by c-section occurs some hours or
days earlier than otherwise would have.
Response: HHS/CDC appreciates the
suggestion to add ‘Method of Delivery’
to the data collection and agrees that
this information could be reliably
reported by the patient. ‘Method of
Delivery (Vaginal or C-section)’ was
added as a proposed data element.
However, ‘Indication for C-Section’ is
usually only available through either the
birth certificate or from the obstetrical
care providers. Collecting information
directly from the obstetrician/
gynecologists is not feasible as part of
this effort.
Appendix—Notice for the Reporting of
Pregnancy Success Rates From Assisted
Reproductive Technology Programs
Introduction
This notice includes four sections:
I. Who Reports: describes who shall report to
HHS/CDC.
II. When and How to Report: describes the
reporting system and process for
reporting by each ART program.
III. What to Report: describes the data items
and definitions to be included in the
reporting database.
IV. Published Reports and Data Usage:
outlines the topics that will be included
in the annual published reports and
describes how data are collected in the
reporting database.
I. Who Reports
The Fertility Clinic Success Rate and
Certification Act of 1992 (FCSRCA) requires
that each assisted reproductive technology
(ART) program shall annually report
pregnancy success rates to the Secretary of
the Department of Health and Human
Services through HHS/CDC. HHS/CDC began
collecting data from ART programs starting
with ART cycles performed in 1995. Between
1997 and 2003, HHS/CDC contracted with
the Society for Assisted Reproductive
Technology (SART) to annually obtain a copy
of their clinic-specific database. Since 2004,
HHS/CDC has maintained the National ART
Surveillance System (NASS), a web-based
ART data reporting system.
The following guidelines have been
established to define an ART program and
the reporting responsibilities of an ART
program, including the responsibilities of
each ART program’s Medical Director.
A. Criteria to be Considered an ART Program
An ART program is defined as a practice,
program, or clinic if it meets the following
criteria:
(1) It is a legal business entity that
practices under State law;
(2) It is recognizable to the consumer as a
stand-alone ART program or clinic, separate
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and apart from another ART program or
clinic with whom that program may share
some or all resources or liability;
(3) It provides ART services to patients
who have experienced infertility or are
undergoing ART for other reasons.
B. Reporting Responsibilities of the Medical
Director
The current Medical Director of the ART
program at the time of the reporting is
responsible for verifying and reporting all
ART cycle data for that reporting year. If the
Medical Director is not available to verify
and approve the reported cycle data due to
unforeseen circumstances, the Laboratory
Director may assume the reporting
responsibilities for the Medical Director. If
there is a change in personnel, including the
Medical Director’s position, between the time
the ART cycles occurred and the time the
reporting year data are due, the current
Medical Director in position at the time of
the final reporting deadline is responsible for
reporting and verifying all ART cycles
performed by that program in that reporting
year.
C. Reporting Responsibilities of ART Program
There are a variety of ways in which ART
programs might be structured. Reporting is
based upon ART cycles performed within a
program not by an individual physician.
Therefore, one or more individual physicians
within a single ART program may not report
their data separately from the remainder of
the physician group. Individual physicians
who practice independently may not pool
their data and report together as one program.
The following sections provide guidance
on the reporting responsibilities for
programs:
(1) One practice, one site—An ART
program with one or more physicians who
share resources and/or liability, but not
necessarily patients, at one location. In a
practice with several physicians, the Medical
Director is required to report every ART cycle
performed at the ART program under one
NASS ID, even when other practitioners in
the ART program may have performed most
or all of the work for the cycle(s). An ART
program cannot report cycles from another
program for which one of their current or
former practice physicians are responsible
except in the case of reorganization.
Reorganization of an ART program is defined
as a change in ownership or affiliation, or
when at least two of the three key staff
positions (Practice Director, Medical
Director, or Laboratory Director) change
because the person(s) in those positions is/
are no longer employed with the practice. In
the case of reorganization, the clinic Medical
Director in position at the time of the final
reporting deadline is responsible for
reporting and verifying all ART cycles
performed by that program in that reporting
year.
(2) One practice, multiple sites—An ART
program with one or more physicians who
share resources and/or liability, but not
necessarily patients, at multiple locations. If
any site satisfies the definition of an
individual ART program as described above
(Section I, A), that site should report
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separately under a unique NASS ID. Contact
the NASS Help Desk at 1–888–650–0822 to
discuss other multiple site scenarios. A
reporting determination will be made based
on the definitions and guidance provided
here.
(3) Multiple ART programs involved in one
cycle—Different ART programs responsible
for ovarian stimulation, oocyte retrieval, and/
or embryo transfer.
The following guidelines should be used:
a. The requirement to report cycles lies
with the ART program that accepts
responsibility for the embryo culture. The
ART programs involved must have a method
in place to ensure that these cycles can be
prospectively reported by the ART program
required to report them. In addition, all
canceled cycles must be reported by the ART
program accepting responsibility for the
embryo culture.
b. Cycles involving previously
cryopreserved oocytes/embryos are to be
reported by the ART program that accepts
responsibility for thawing the oocytes/
embryos.
(4) Multiple ART programs sharing one
ART laboratory—Independent ART programs
that share an embryology laboratory or use
another program’s laboratory must report
their cycles independently under their own
unique NASS IDs.
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II. When and How To Report
A. Reporting Activities
The deadline for reporting ART cycle and
pregnancy outcome data to HHS/CDC is
December 15 of the year after which cycles
were conducted. For example, the deadline
to report data on cycles initiated between
January 1, 2013 and December 31, 2013 was
December 15, 2014. HHS/CDC will send a
letter to all qualifying ART programs to
announce each reporting year deadline 90
days before cycle data are due. An ART
program is considered to be non-compliant
with the federal reporting requirements of the
FCSRCA if the program was in operation at
any time during the reporting year and
performed any ART cycles and (a) fails to
submit ART cycle data to HHS/CDC by the
reporting deadline, or (b) the program’s
Medical Director fails to verify the clinic
success rates table by the reporting deadline.
These programs will be identified as nonreporters in HHS/CDC’s annual Assisted
Reproductive Technology Fertility Clinic
Success Rates Report. ART programs that
were in operation at any time during the
reporting year but did not perform any ART
cycles will not be included in HHS/CDC’s
annual ART report (either as a reporting or
as a non-reporting clinic).
ART programs that are submitting data to
HHS/CDC via the NASS or through an
approved alternative (i.e., SART member
clinics may report their data to NASS
through SART) will be considered to be in
compliance with federal reporting
requirements of the FCSRCA. Regardless of
the method chosen for submitting data to
NASS, each clinic must complete the annual
submission steps as detailed in the NASS
Annual Submission Guide posted on the
NASS Web site (www.artreporting.org). A
NASS account can be set up by calling the
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NASS Help Desk at 1–888–650–0822 or by
sending an email to NASS@artreporting.org.
NASS accounts established previously can be
used for data submission by the same clinic,
although user passwords may need to be reestablished if they have expired since last
using NASS. ART programs should also
notify the NASS Help Desk of any changes
in clinic location, ownership, or key staff
(i.e., Practice, Medical, or Laboratory
Director) and provide NASS with a list of all
practicing physicians in the program.
All cycle data must be reported
prospectively, i.e., reporting of initial cycle
intent and select patient details is required
within four days of cycle initiation. Each
ART patient will be assigned a unique,
system-generated patient ID when the
program first enters the patient in NASS. The
program is responsible for linking each
patient’s ID to the patient’s medical records
for reporting any future ART cycles. Each
ART cycle for each patient is also assigned
a unique cycle code. In NASS, the patient is
identified by the NASS ID and the patient ID;
the cycle code (cycle IDs) allows
identification of all cycles performed on a
single patient. Since the patient’s name and
social security number are not included in
the reporting database, each program should
maintain personal identifiers in the
program’s database on site in order to link
every cycle reported to CDC to a specific
patient.
B. Updating of Reporting Requirements
ART is a rapidly developing medical
science. To keep current as practices evolve,
ART reporting requirements, including data
collection instruments, variables, and
definitions, will be periodically reviewed
and updated as new knowledge concerning
ART methods and techniques becomes
available. During such a review, professional
and consumer groups and individuals will be
consulted to confirm the validity of the new
or revised reporting requirements and data
elements. Clinics will be notified in writing
at least 120 days in advance of January 1st
of the reporting year of all changes to the
reporting requirements.
ART programs are ultimately responsible
for ensuring that their data are mapped
accurately into the required NASS format if
using third-party electronic medical records
or reporting systems to submit their ART data
through NASS to HHS/CDC. ART programs
must ensure their clinic data can be correctly
transmitted to NASS for pre-import NASS
quality control reviews and imported into
NASS in time for the required NASS annual
submission steps by the HHS/CDC deadline.
HHS/CDC will continue to inform clinics of
all necessary requirements for importing data
from other electronic medical record systems
into NASS and for checking imported data to
ensure that it retains the accuracy and
compatibility of the data entry system from
which it was extracted.
Each ART program should be aware that
the Paperwork Reduction Act is applicable to
this data collection. Under the Paperwork
Reduction Act of 1995, a Federal agency shall
not conduct or sponsor a collection of
information from ten or more persons other
than Federal employees, unless the agency
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has obtained approval from the Office of
Management and Budget (OMB) for the
collection of information. A person is not
required to respond to a collection of
information unless it displays a currently
valid OMB control number. In compliance
with the Paperwork Reduction Act, HHS/
CDC has obtained OMB approval to collect
this data under OMB control No. 0920–0556,
expiration 07/31/2018.
C. External Validation of Clinic Data
As part of the annual routine activities of
this surveillance program, all ART programs
are subject to external validation of their
reporting activities, which will include
review by appropriate professionals from
CDC staff and CDC contractors. This review
may include but is not limited to
examination of medical and laboratory
records and comparison with data reported
in NASS.
Each year, HHS/CDC selects a random
sample of 5–10% of all reporting ART
programs, after taking into consideration
some clinic characteristics, e.g., size of
clinics, number of cancelled cycles, or
number of multiple births for an on-site
validation visit. The purpose of validation is
to evaluate the overall accuracy of data
reported in NASS. It also serves to identify
any systematic problems that could cause
data collection to be inconsistent or
incomplete. During validation visits, data
submitted to NASS are compared with data
recorded in the patient medical records,
which allows for the calculation of
discrepancy rates. All potential data
discrepancies identified during the on-site
visit will be discussed with staff of the ART
program. If major data discrepancies are
identified during data validation (e.g., lack of
supporting information for pregnancy
outcomes, underreporting cycles, etc.), HHS/
CDC may re-select these ART programs for
data validation during the following
reporting year(s) to assess corrections of
identified data errors. Aggregate findings for
validated data fields from all ART programs
participating in validation will be reported in
HHS/CDC’s Fertility Clinic Success Rates
Report. The HHS/CDC validation process is
not an assessment of clinical practice or
overall record keeping; however, the results
of the validation may be helpful to ART
programs.
Each clinic is responsible for maintaining
appropriate medical and laboratory records
that contain information reported in NASS.
This information must be able to link each
patient, cycle, oocyte retrieved, transfer, and
pregnancy outcome for the purpose of
external validation.
III. What To Report
Cycle-specific data for the following
patients must be reported: (1) All patients
undergoing ART, (2) all patients undergoing
ovarian stimulation or monitoring with the
intent of undergoing ART but who did not
proceed to oocyte retrieval or transfer of
embryos for any reason, including patients
whose cycles were canceled for any reason,
(3) all patients providing donor oocytes, and
(4) all patients undergoing monitoring and/or
embryo (or oocyte) thawing with the
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intention of transferring cryopreserved
embryos. Only cycles performed in the U.S.
may be reported to CDC. ART programs must
report the following data items:
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A. Patient Demographic Information
Date of Cycle Reporting
NASS ID
Optional Identifier (as needed)
Date of Birth
Gender
U.S. Residency
City of Residence
State of Residence
Country of Residence (if not United States)
D. Oocyte Source and Carrier Information
Date of Birth
Race (White, Black, Asian, Native Hawaiian/
Pacific Islander, American Indian or
Alaska Native)
Ethnicity (Hispanic, non-Hispanic, Refused,
Unknown)
B. Cycle Information
1. Intended Cycle Information
Intended Type of Cycle (IVF, GIFT, ZIFT,
Oocyte or embryo banking)
Intended Embryo Source (Patient, Donor)
Intended Embryo State (Fresh, Frozen)
Intended Oocyte Source (Patient, Donor)
Intended Oocyte State (Fresh, Frozen)
Intended Sperm Source (Partner, Donor,
Patient, Unknown)
Pregnancy Carrier (Patient, gestational
carrier, none-for oocyte/embryo banking
only)
2. Cycle Information
Type of Cycle (IVF, GIFT, ZIFT, Oocyte or
embryo banking)
Embryo Source (Patient, Donor)
Embryo State (Fresh, Frozen)
Oocyte Source (Patient, Donor)
Oocyte State (Fresh, Frozen)
3. Patient Medical Evaluation
Reason(s) for ART
Male Infertility (Medical condition,
Genetic or chromosomal abnormality,
abnormal sperm parameters, Obstructive
azoospermia, Non-obstructive
azoospermia, Severe oligospermia,
Moderate oligospermia, Low motility,
Low morphology, other)
History of Endometriosis
Tubal Ligation for Contraception
Current or Prior Hydrosalpinx
Other Tubal Disease (Not Current or
Historic Hydrosalpinx)
Ovulatory Disorders (PCO, Other)
Diminished Ovarian Reserve
Uterine Factor
Preimplantation Genetic Diagnosis as
Primary Reason for ART
Oocyte or Embryo Banking As Reason for
ART
Indication for Use of Gestational Carrier
(Absence of uterus, Significant uterine
anomaly, Medical contraindication to
pregnancy, Recurrent pregnancy loss,
Unknown)
Recurrent Pregnancy Loss
Other Reasons Related to Infertility
(Specify)
Other Reasons Not Related to Infertility
(Specify)
Unexplained Infertility
C. Patient History
Height
Weight
History of Smoking
History of Prior Pregnancy (Number of prior
full term, preterm, stillbirth,
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spontaneous, ectopic pregnancies)
Months attempting pregnancy
History of Prior ART (Fresh & Frozen)
Maximum FSH Level (mIU/mL)
Recent AMH Level (ng/mL)
Date of Most recent AMH Level
E. Sperm Source Information
Date of Birth
Race (White, Black, Asian, Native Hawaiian/
Pacific Islander, American Indian or
Alaska Native)
Ethnicity (Hispanic, non-Hispanic, Refused,
Unknown)
F. Stimulation and Retrieval
Stimulation
Aromatase Inhibitor/Estrogen Receptor
Medication (Clomiphene and Letrozole
dosage)
FSH Medication
LH/HCG Medication
GnRH (Gonadotropin-releasing
hormone)(None, GnRH agonist
suppression, GnRH agonist flare, GnRH
Antagonist suppression)
Canceled Cycle
Date of Canceled Cycle
Reason for Canceled Cycle (Low ovarian
response, High ovarian response,
Inadequate endometrial response,
Concurrent illness, Withdrawal for
personal reasons, Other)
Date of Retrieval
Number of Patient Oocytes Retrieved
Number of Donor Oocytes Retrieved
Use of Oocytes (For this cycle, Oocytes
frozen for future use, Oocytes shared
with other patients, Embryos frozen for
future use)
Complications of Stimulation and Retrieval
(Infection, Hemorrhage, Ovarian
Hyperstimulation requiring intervention
or hospitalization, Medication Side
Effect, Anesthetic Complication,
Thrombosis, Death, Other) Sperm Status
(Fresh, Thawed, Mix of fresh and
thawed) Sperm Source Utilized
(Ejaculated, Epididymal, Testis,
Electroejaculation, Retrograde urine,
Donor, Unknown)
G. Laboratory Information
ICSI (Intracytoplasmic sperm injection) (All
oocytes, Some oocytes, No oocytes,
Unknown)
Indication for ICSI (Prior failed fertilization,
Poor fertilization, PGD, Abnormal semen
parameters, Low oocyte yield, Laboratory
routine, Frozen cycle, Rescue ICSI,
Other)
IVM (In vitro maturation)
PGD (Pre-implantation genetic diagnosis)
PGS (Pre-implantation genetic screening)
Reasons for PGD/PGS
Technique(s) Used for PGD/PGS
Assisted Hatching
2 Pronuclei
Research Cycle
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SART Approval Code for Research Cycle
H. Transfer Information
Attempted Transfer
Reason for No Transfer (Low Ovarian
Response, High Ovarian Response,
Failure to Survive Thaw, Inadequate
Endometrial Response, Concurrent
Illness, Patient Withdrawal from
Treatment, Unable to Obtain Sperm
Specimen, Insufficient Embryos, Other)
Date of Transfer
Endometrial Thickness
1. Fresh Embryo Transfer
Number of Fresh Embryos Available for
Transfer
Number of Fresh Embryos Transferred
eSET
Quality of Embryo (Good, Fair, Poor,
Unknown)
Number of Fresh Embryos Cryopreserved
2. Thawed Embryo Transfer
Number of Thawed Embryos Available for
Transfer
Number of Thawed Embryos Transferred
Quality of Embryo
Date of Oocyte retrieved for the Thawed
Embryos
Number of Thawed Embryos Cryopreserved
3. GIFT/ZIFT/TET Transfer (for Non-IVF
Cycle)
Number of Oocytes/Embryos Transferred to
Fallopian Tube
I. Outcome Information
Outcome of Treatment (Not Pregnant,
Biochemical Pregnancy, Ectopic
Pregnancy, Clinical Intrauterine
Gestation, Heterotopic Pregnancy,
Unknown)
Maximum Number of Fetal Hearts
Ultrasound Date
If >2 Fetal Hearts, any Monochorionic Twins/
Multiples
Outcome of Pregnancy (Live Birth, Stillbirth,
Spontaneous Abortion, Induced
Abortion, Maternal Death Prior to Birth,
Unknown)
Date of Pregnancy Outcome
Method of delivery (Vaginal, Cesarean
section)
Source for Outcome of Pregnancy (Verbal
Confirmation Patient, Written
Confirmation Patient, Verbal
Confirmation Physician or Hospital,
Written Confirmation Physician or
Hospital)
Method of Delivery (Vaginal, Cesarean
section)
Number of Infants Born
Birth Status (Live Birth, Stillbirth, Unknown)
Gender of Infant (Each Live-born and
Stillborn Infant)
Birth Weight (Each Live-born and Stillborn
Infant)
Birth Defect (Each Live-born and Stillborn
Infant) (Genetic Defect/Chromosomal
Abnormality, Cleft Lip or Palate, Neural
Tube Defect, Cardiac Defect, Limb
Defect, Other Defect)
J. Definitions
The following definitions provide
clarification for the required data items:
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Assisted reproductive technology (ART)—
All treatments or procedures that include the
handling of human oocytes or embryos for
the purpose of establishing a pregnancy. This
includes, but is not limited to in vitro
fertilization and transcervical embryo
transfer, gamete intrafallopian transfer,
zygote intrafallopian transfer, tubal embryo
transfer, oocyte or embryo cryopreservation,
oocyte or embryo donation, and gestational
surrogacy. ART does not include assisted
insemination using sperm from either a
woman’s partner or sperm donor.
ART cycle—ART cycles can be stimulated
(use of ovulation induction) or unstimulated
(natural cycle). An ART cycle is considered
any cycle in which (1) ART has been used,
(2) the woman has undergone ovarian
stimulation or monitoring (i.e., performance
of sonogram, serum estradiol or LH
measurements) with the intent of undergoing
ART, (3) in the case of donor oocytes, a
woman began medication for endometrial
preparation with the intent of undergoing
ART, or (4) in the case of cryopreserved
embryos or oocytes, a woman began
medication for endometrial preparation with
the intent of undergoing ART and/or embryos
were thawed with the intent of transfer.
Anti-mullerian hormone (AMH) level—A
measure of diminished ovarian reserve that
predicts the ovaries’ response to ovarian
stimulation during ART.
Assisted hatching—A micromanipulation
technique that involves making a small
opening in the zona wall of the embryo in an
effort to enhance implantation.
Azoospermia, obstructive—Complete
absence of sperm from the ejaculate.
Obstructive azoospermia may result from
epididymal, vasal, or ejaculatory duct
pathology.
Azoospermia, non-obstructive—Complete
absence of sperm in the ejaculate due to
testicular failure, varicoceles, or
chromosomal abnormalities such as Ychromosome microdeletions or karyotypic
abnormalities (e.g., Klinefelter syndrome).
Birth defect—Anomaly diagnosed prior to
or at birth that results in death or causes a
serious disability requiring surgical and/or
medical therapy. Specific anomalies to be
identified include genetic defect/
chromosomal abnormality, cleft lip or palate,
neural tube defect, cardiac defect, limb
defect, or other defect.
Biochemical pregnancy—A positive serum
pregnancy test (Beta-hCG) without
ultrasound confirmation of a gestational sac
within the uterus, and without diagnosis of
an ectopic pregnancy.
Blastocyst/trophectoderm biopsy—
Procedure involving the removal of a small
number of trophectoderm cells from a
blastocyst stage embryo for genetic testing. A
blastocyst is a day 5/6 embryo which
contains two cell types—the inner cell mass,
which eventually develops into fetal tissues,
and the trophectoderm, which gives rise to
the developing placenta and other tissues.
Blastomere biopsy—Procedure involving
the removal of one blastomere from a
cleavage stage embryo for genetic testing. A
cleavage stage embryo is a day 3 embryo
when approximately 6–8 cells are present.
Cancelled cycle—An ART cycle in which
ovarian stimulation or monitoring or
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endometrial preparation has been carried out
with the intent of undergoing ART but which
did not proceed to oocyte retrieval or to the
transfer of embryos. Reasons for cancellation
include low ovarian response, high ovarian
response, inadequate endometrial response,
concurrent illness, patient withdrawal from
treatment, failure of oocytes to survive thaw,
an inability to obtain sperm specimen, or
insufficient embryos.
Clinical pregnancy/Clinical intrauterine
gestation—An ultrasound-confirmed
gestational sac within the uterus or the
documented occurrence of a birth,
spontaneous abortion, or induced abortion in
cases of missing ultrasound data. Clinical
pregnancies include all gestational sacs
regardless of whether or not a heartbeat is
observed or a fetal pole is established. This
definition excludes ectopic pregnancy but
includes pregnancies which end in live birth,
stillbirth, spontaneous abortions, and
induced abortions.
Clomiphene citrate—An ovulation
induction medication with trade names such
as Clomid®, Serophene®, or Milophene®.
Complication—A medical complication for
the woman related to ART procedures.
Specific complications to be identified
include infection, hemorrhage requiring
transfusion, ovarian hyperstimulation
syndrome requiring intervention or
hospitalization, medication side effect,
anesthetic complication, thrombosis, death of
patient, or other specified complication.
Cryopreservation—A technique used in
ART to preserve sperm, oocytes, and embryos
through freezing.
Cycle start date (cycle initiation date)—
(1) For fresh embryo, (both donor and nondonor): The first day that medication to
stimulate follicular development is given in
a stimulated cycle or the first day of menses
in an unstimulated cycle. For example:
a. The first day of gonadotropins in a
gonadotropin only cycle or in a long
suppression GnRH agonist-gonadotropin
cycle;
b. The first day of GnRH agonist in a GnRH
agonist flare-gonadotropin cycle;
c. The first day of clomiphene or letrozole
in a clomiphene/gonadotropin cycle or a
clomiphene only cycle;
d. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(2) For fresh embryo donor cycles:
a. The first day exogenous sex steroids are
given to patient to prepare the endometrium;
b. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(3) For frozen embryo cycles (both donor
and non-donor):
a. The first day exogenous sex steroids are
given to prepare the endometrium;
b. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
(4) For oocyte/embryo banking cycles:
a. The first day of gonadotropins in a
gonadotropin only cycle or in a long
suppression GnRH agonist-gonadotropin
cycle;
b. The first day of GnRH agonist in a GnRH
agonist flare-gonadotropin cycle;
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c. The first day of clomiphene or letrozole
in a clomiphene/gonadotropin cycle or a
clomiphene only cycle;
d. The first day of natural menses or
withdrawal bleeding in an unstimulated
cycle.
Diminished ovarian reserve—A condition
of reduced fecundity related to diminished
ovarian function based on clinical
assessment; often indicated by FSH≤10 mIU/
mL or AMH<1.0 ng/mL.
Donor embryo cycle—A cycle initiated
with the intent to transfer donated embryos,
that is, embryos derived from oocytes
previously fertilized for another couple’s
ART therapy that were subsequently
donated.
Donor oocyte cycle—A cycle initiated with
the intent to transfer oocytes, or embryos
derived from oocytes that were retrieved
from a woman serving as an oocyte donor
(sperm source may be either the patient’s
partner or a sperm donor selected by the
patient).
Ectopic pregnancy—A pregnancy in which
the fertilized egg implants outside the uterine
cavity.
Elective single embryo transfer—A
procedure in which one embryo, selected
from a larger number of available embryos, is
placed in the uterus or fallopian tube. The
embryo selected for eSET might be from a
previous IVF cycle (i.e.; cryopreserved
[frozen] embryos) or from a current fresh IVF
cycle that yielded more than one embryo.
The remaining embryos may be set aside for
future use through cryopreservation.
Embryo—The normally (2 pronuclei)
fertilized egg that has undergone one or more
divisions.
Embryo banking cycle—A cycle initiated
with the intent of cryopreserving all embryos
for later use. (This does not apply to cycles
initiated with the intent to transfer embryos
but for which all embryos were subsequently
cryopreserved regardless of the reason.)
Embryo banking can be short term (<12
months) or long term (≥12 months).
Embryo quality—Refers to the quality of
the embryo as determined by its morphology.
Embryo morphology assessment includes two
parts: an overall grade and the stage. Overall
grading is a subjective assessment of the
overall quality of the embryo as good, fair or
poor, and is based on assessment of certain
characteristics of the embryo, such as
fragmentation, symmetry, inner cell mass
(ICM) quality or trophectoderm quality. Stage
dependent grading involves determining the
developmental stage of the embryo.
—Good: Embryo free of imperfections or with
only minor imperfections.
—Fair: Embryo lacking exceptional quality
but not excessively imperfect either.
—Poor: Embryo with numerous
imperfections.
Embryo transfer—Attempt to introduce
embryo(s) into a woman’s uterus or attempt
to introduce embryos or gametes (oocytes and
sperm) into a woman’s fallopian tubes; a
transfer procedure is considered to have been
carried out, if attempted, even if no embryos
or gametes were successfully transferred.
Endometriosis—The presence of tissue
resembling endometrium in locations outside
the uterus such as the ovaries, fallopian
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tubes, and abdominal cavity; a history of all
stages of endometriosis (minimal to severe)
whether treated or not may be a reason for
ART.
Endometrium—The lining of the uterus
that is shed each month as the menstrual
period. As the monthly cycle progresses, the
endometrium thickens and thus provides a
nourishing site for the implantation of a
fertilized egg.
Fertilization—The penetration of the egg by
the sperm and fusion of genetic materials to
result in the development of a fertilized egg
(or zygote).
Fetus—The developmental stage during
pregnancy from the completion of embryonic
development at eight weeks of gestation until
delivery.
Flare protocol—A stimulation protocol in
which a GnRH agonist is started on day 2 of
the same menstrual cycle during which the
eggs will be retrieved.
Follicle—A fluid-filled sac located just
beneath the surface of the ovary that contains
an oocyte and cells that produce hormones.
Fresh embryo—An embryo created during
the current cycle (either from the patient or
donor), i.e., not a thawed embryo created
during a previous cycle. Fresh embryos can
be created from either fresh or frozen eggs or
sperm.
Fresh oocyte—An oocyte retrieved during
the current cycle (either from the patient or
donor), i.e., not a thawed oocyte retrieved
during a previous cycle.
Follicle stimulating hormone (FSH)—A
gonadotropin hormone produced and
released from the pituitary that stimulates the
ovary to ripen a follicle for ovulation. FSH
is available in several types of preparations
including: Urofollitropin, Follitropin alfa and
Follitropin beta, some of which also include
luteinizing hormone (LH). Trade names
include Gonal-f®, Metrodin®, FertinexTM,
BravelleTM, Repronex®, Pergonal®,
Humegon®, and FollistimTM.
Full-term birth—A birth that reached 37
completed weeks of gestation. This includes
both live births and stillbirths. For the
purpose of reporting prior full-term births,
births are counted as birth events (e.g., a
triplet birth is counted as one).
Gamete intrafallopian transfer (GIFT)—An
ART procedure that involves removing
oocytes from a woman’s ovary, combining
them with sperm, and immediately
transferring (via a catheter) the eggs and
sperm into the fallopian tube. Fertilization
takes place inside the fallopian tube.
Gestational carrier (sometimes referred to
as a gestational surrogate)—A woman who
gestates an embryo that did not develop from
her oocyte, with the expectation of returning
the infant to its intended parent(s). NOTE:
For female same sex couples, the woman
who will carry the pregnancy should be
identified as the patient and a separate cycle
should be reported if donor oocytes are used,
even if the patient’s partner is the source of
the oocytes. If a gestational carrier is used,
one cycle is reported for fresh embryo cycle;
two cycles should be reported for frozen
embryo cycle (one for the oocyte retrieval
and one for the embryo transfer).
Gonadotropin—Hormones having a
stimulating effect on the gonads (ovaries and
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testes). Two such hormones are secreted by
the anterior pituitary: follicle stimulating
hormone (FSH) and luteinizing hormone
(LH). Gonadotropins (FSH, either alone or
with LH) are also included in drug
preparations used to stimulate follicular
development during an ART cycle.
Gonadotropin-releasing hormone (GnRH)—
A hormone secreted by the hypothalamus
which induces the pituitary gland to release
follicle stimulating hormone (FSH) and
luteinizing hormone (LH) into the
bloodstream.
—GnRH agonists—synthetic hormones that
stimulate and then suppress the secretion
of FSH and LH
—GnRH antagonists—synthetic hormones
that suppress the secretion of FSH and LH
Gravidity—Total number of prior pregnancies
a patient has had. This includes ectopic
pregnancies, biochemical pregnancies, and
pregnancies that ended in therapeutic
abortion, spontaneous abortion, stillbirth,
or live birth.
Heterotopic pregnancy—A clinical
intrauterine gestation in combination with an
ectopic pregnancy.
Human chorionic gonadotropin (HCG)—A
hormone produced by the placenta after
implantation. It is used during ART to cause
ovulation.
Hydrosalpinx (current and prior)—
Accumulation of watery fluid in a fallopian
tube that usually results from damage to the
tube.
—Communicating: Patent fallopian tube.
Non-occluded.
—Occluded: Non-communicating fallopian
tube. Occlusion may be by means of
salpingectomy, tubal ligation, or
hysteroscopic occlusion.
Induced abortion—Operative or medical
intervention to electively terminate the entire
pregnancy (no gestational age limit).
Intracytoplasmic sperm injection (ICSI)—
The placement of a single sperm into the
ooplasm of an oocyte by micro-operative
techniques.
In vitro fertilization (IVF)—A method of
assisted reproduction that involves removing
oocytes from a woman’s ovaries, combining
them with sperm in the laboratory, and after
fertilization is confirmed, replacing the
resulting embryo into the woman’s uterus.
In vitro maturation (IVM)—Procedure in
which eggs are removed from the ovaries and
are collected when they are still immature.
They are then matured in the laboratory
before being fertilized.
Letrozole— An ovulation induction
medication, such as the medication with the
trade name Femara ®.
Live birth—A birth (delivery) in which at
least one fetus was live born, i.e., showed
signs of life after the complete expulsion or
extraction from its mother or gestational
carrier. Signs of life include breathing,
beating of the heart, pulsation of the
umbilical cord, or definite movement of the
voluntary muscles. Any birth event in which
an infant shows signs of life should be
counted as a live birth, regardless of
gestational age at birth. Live births are
counted as birth events (e.g., a triplet live
birth is counted as one).
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Low sperm motility—Sperm motility less
than laboratory norm (varies by method
used).
Low sperm morphology—Sperm
morphology less than laboratory norm (varies
by method used).
Luteinizing hormone (LH)—A
gonadotropin hormone produced and
released from the pituitary that stimulates the
ovary to ripen a follicle for ovulation.
Male infertility—Infertility due to abnormal
semen parameters or abnormal sperm
function.
Method of delivery—Method used to
deliver infant(s), vaginal or Cesarean section.
Monochorionic—When two or more
embryos or fetuses share the same chorion
and the same placenta.
NASS ID—An identification number
assigned to each ART clinical program by the
reporting database operator.
Oligospermia—Semen with a low
concentration of sperm. Severe oligospermia
is defined by <5 million spermatozoa per mL;
moderate is defined by 5–15 million
spermatozoa per ml.
Oocyte—The female reproductive cell, also
called an egg.
Oocyte banking—A cycle initiated with the
intent of cryopreserving all un-fertilized
oocytes for later use. This does not apply to
cycles initiated with the intent to transfer
embryos. Oocyte banking can be short term
(<12 months) or long term (≥12 months).
—Autologous oocyte banking—refers to
cycles where the patient is banking her
own oocytes for later use.
—Donor oocyte banking—refers to cycles
where a donor is banking oocytes for use
by someone else at a later date.
Oocyte donor—A woman who undergoes
an oocyte retrieval procedure with the intent
of donating the oocytes retrieved to a
couple(s) undergoing an ART donor oocyte
cycle (see donor oocyte cycle).
Oocyte retrieval—A procedure to collect
the eggs contained within the ovarian
follicles. This definition includes procedures
in which oocyte recovery was attempted but
not successful.
Oocyte transfer—In GIFT (see definition),
transfer of retrieved eggs into a woman’s
fallopian tubes. Includes attempted transfers,
whether or not the transfer was successful.
Ovarian monitoring—Monitoring the
development of ovarian follicles by
ultrasound and/or blood or urine tests.
Ovarian stimulation—Use of one or more
follicle stimulation medications to stimulate
the ovary to develop follicles and oocytes.
Ovarian hyperstimulation requiring
intervention or hospitalization—
Hyperstimulation may be evidenced by
abdominal distension and discomfort;
nausea, vomiting, and/or diarrhea; ovaries
enlarged 5–12 cm; ultrasonic evidence of
ascites; clinical evidence of ascites and/or
hydrothorax or breathing difficulties; change
in blood volume; increased blood viscosity
due to hemoconcentration; coagulation
abnormalities; diminished renal perfusion
and function, -hematocrit >50%; and
requiring intervention such as paracentesis or
hospitalization.
Ovulatory disorder—One or more disorders
causing reduced fecundity that is associated
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with structural, anatomic, or functional
impairment of one or both ovaries; includes
polycystic ovary syndrome (PCOS), oligoovulation (≤6 cycles per year), and
anovulation (of hypothalamic or nonhypothalamic causes) such as functional
hypothalamic amenorrhea (FHA).
Ovulation induction—See stimulated
cycle.
Patient—Generally defined as the female
undergoing treatment. More specifically:
—For heterosexual couples, the patient is
always the female partner.
—For male same-sex couples, the male
providing sperm is the patient. If both male
partners or neither male partner is
providing sperm, select one male to
identify as the patient.
—For female same-sex couples, the patient is
the female intending to carry the
pregnancy. If neither female intends to
carry the pregnancy (i.e. a gestational
carrier will be used) the patient is the
female providing the oocyte. If both
females are providing oocytes, the patient
is the youngest female providing oocytes.
If neither female intends to carry the
pregnancy or provide oocytes (i.e. donor
oocytes are used with a gestational carrier),
select one female to identify as the patient.
Pituitary—A small gland just beneath the
hypothalamus in the brain which controls
other hormone producing glands such as the
ovaries, thyroid, and adrenal glands. Ovarian
function is controlled through the secretion
of follicle stimulating hormone (FSH) and
luteinizing hormone (LH) from the pituitary.
Polar body biopsy—Polar bodies are the byproducts of egg division. These cells do not
serve any role for the egg or embryo and will
naturally degrade; however, they can be
removed and tested to determine the genetic
status of the egg. Polar body testing only tests
for the maternal genetic contribution to the
embryo. Polar body biopsy occurs at the day
0 and/or day 1 stage. Both polar bodies must
be removed and tested in order to make an
accurate diagnosis.
Pregnancy test—A blood test that
determines the level of human chorionic
gonadotropin (hCG), a hormone produced by
the placenta; if it is elevated, this confirms
a pregnancy, which may be biochemical
only, ectopic, or clinical intrauterine
gestation (normally developing pregnancy).
Preimplantation genetic diagnosis (PGD)—
Characterization of a cell or cells from preimplanted embryos from IVF cycles to
determine the presence or absence of a
specific genetic defect.
Preimplantation genetic screening (PGS)—
Characterization of a cell or cells from preimplanted embryos from IVF cycles to
identify genetic abnormalities.
Preterm birth—Birth at least 20 but less
than 37 completed weeks of gestation. This
includes both live births and stillbirths. For
the purposes of reporting prior preterm
births, births are counted as birth events (e.g.
a triplet birth is counted as one).
Recipient—In an ART cycle, the woman in
whom embryos or oocytes are transferred;
includes the female patient or a gestational
carrier for the patient.
Recurrent pregnancy loss—A disease
distinct from infertility, defined by two or
more failed pregnancies.
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Semen—Fluid discharged at ejaculation in
male.
Sperm—The male reproductive cell that
has completed the process of meiosis and
morphological differentiation. Sperm used
for ART can be obtained using different
methods:
—Ejaculation—Sperm is collected from a
semen sample obtained by ejaculation, the
release of semen from the penis during
orgasm.
—Electroejaculation—This procedure is used
in men who have a neurologic ejaculatory
disorder, such as spinal cord injury or
psychogenic anejaculation, without
mechanical obstruction of the excurrent
ductal system. This procedure involves the
use of electricity to directly stimulate the
ejaculatory organs.
—Epididymal aspiration—A technique in
which sperm is aspirated and sampled
percutaneously from the epididymis.
—Retrograde ejaculation—Ejaculation in
which semen travels up the urethra
towards the bladder instead of to the
outside of the body. Sperm can be
collected directly from the bladder or from
voided urine.
—Testicular biopsy—Sperm are obtained
from a biopsy of seminiferous tubules.
Sperm donor—A man providing sperm for
the fertilization of oocytes of a woman other
than his sexual partner.
Spontaneous abortion (miscarriage)—A
clinical pregnancy ending in spontaneous
loss of the entire pregnancy prior to
completion of 20 weeks of gestation (or 18
weeks from the date of transfer if the
pregnancy was achieved using ART).
Stillbirth—Birth (delivery) at 20 weeks of
gestation or later (or 18 weeks or later from
the date of transfer if the pregnancy was
achieved using ART) in which no fetus
showed signs of life after the complete
expulsion or extraction from the mother.
Stillbirths are counted as birth events (e.g. a
triplet stillbirth is counted as one).
Stimulated cycle—An ART cycle in which
a woman receives medication to stimulate
follicular development including the use of
clomiphene citrate, follicle stimulating
hormone (FSH), or follicle stimulating
hormone and luteinizing hormone (FSH and
LH).
Surgical sterilization—An operative
procedure for the purpose of termination of
fertility. Surgical sterilization includes tubal
ligation, salpingectomy,vasectomy and
hysterectomy.
Thawed oocyte—Oocyte retrieved during a
previous cycle, cryopreserved, and then
thawed for use during the current cycle
(either from the patient or donor), i.e., not a
fresh oocyte retrieved during the current
cycle.
Thawed embryo—Embryo created during a
previous cycle, cryopreserved, and then
thawed for use during the current cycle
(either from the patient or donor), i.e., not a
fresh embryo created during the current
cycle. Frozen embryos can be created from
either fresh or frozen eggs and sperm.
Thrombosis—Formation of a blood clot in
a vessel obstructing the flow of blood through
the circulatory system.
Tubal embryo transfer (TET)—Transfer of
an early stage embryo to the fallopian tube.
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Fmt 4703
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Tubal factor—A factor causing reduced
fecundity that is associated with structural,
anatomic, or functional injury of one or both
fallopian tubes; the following are included:
(1) Tubal ligation, not reversed, (2)
hydrosalpinx (in place), 3 History of
hydrosalpinx (treated—by either surgical
removal or hysteroscopic occlusion) and (4)
any other tubal disease including but not
limited to pelvic or peritubal adhesive
disease, prior tubal surgery, prior ectopic
pregnancy, or tubal occlusion (partial or
complete without hydrosalpinx).
Tubal ligation for contraception—
Sterilization of the female by constricting,
severing, or crushing the fallopian tubes;
constriction may be with an encircling
plastic ring or other ligature.
Ultrasound—A technique for visualizing
the follicles in the ovaries and the gestational
sac or fetus in the uterus, allowing the
estimation of size.
Unexplained infertility—Infertility in
which no etiology (male infertility,
endometriosis, tubal factor, ovulatory
disorders/PCO, diminished ovarian reserve,
uterine factor, or other factors (such as
immunologic, chromosomal, cancer
chemotherapy or other systemic disease) has
been identified.
Unstimulated cycle—An ART cycle in
which the woman does not receive
medication to stimulate follicular
development such as clomiphene or follicle
stimulating hormone. Instead, natural
follicular development occurs.
Uterine factor—A factor causing reduced
fecundity that is associated with structural,
anatomic, or functional injury to the uterus
whether repaired or not; includes septum,
myoma, Diethylstilbestrol (DES) exposure,
intrauterine adhesions, congenital anomalies.
Zygote—A normal (2 pronuclei) fertilized
egg before cell division begins.
Zygote intra fallopian transfer (ZIFT)—
Eggs are collected and fertilized, and the
resulting zygote is then transferred to the
fallopian tube.
2 Pronuclei (2PN)—The earliest stage of
embryonic development that occurs just after
fertilization but before the nucleus from the
sperm and the egg have fused (thus, 2
pronuclei are present). The appearance of
two pronuclei indicates normal fertilization
and is usually detected 16–20 hours after
fertilization or insemination.
IV. Published Reports and Data Usage
A. Annual ART Reports
ART data are used to produce the annual
Assisted Reproductive Technology Fertility
Clinic Success Rates Report, a key
publication available to Congress, individual
clinics, consumers, the states, and the general
public. This report has 3 major sections:
(a) Commonly asked questions—provides
background information and an explanation
of the data reporting process.
(b) Fertility clinic table—displays tabulated
results of success rates for all reported ART
procedures at individual U.S. fertility clinics.
(c) Appendices—contains summary of data
validation; a glossary of technical and
medical terms used in the report; the names,
addresses, and telephone numbers of all
reporting and non-reporting clinics; and a list
E:\FR\FM\26AUN1.SGM
26AUN1
Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices
of national consumer organizations offering
support to people experiencing infertility.
In addition, HHS/CDC publishes an annual
Assisted Reproductive Technology National
Summary Report using pooled data presented
as graphs and charts to provide an in-depth
picture of the type, number, and outcomes of
ART cycles performed in the United States.
HHS/CDC also uses the pooled data to
publish an annual ART Surveillance
Summary in HHS/CDC’s Morbidity and
Mortality Weekly Report (MMWR) with statespecific information on ART procedures and
their outcomes. These reports are primarily
used by states for state-based surveillance
and to inform maternal and child health
programs.
Dated: August 19, 2015.
Pamela J. Cox,
Director, Division of the Executive Secretariat,
Office of the Chief of Staff, Centers for Disease
Control and Prevention.
B. Data Usage and Data Access
AGENCY:
The average cost per inspection is
multiplied by size and cost factors to
determine the fee for vessels in each
size category. The size and cost factors
were established in the fee schedule
published in the Federal Register on
July 17, 1987 (52 FR 27060). The fee
schedule was most recently published
in the Federal Register on July 31, 2014
(79 FR 44454). The size and cost factors
for FY 2016 are presented in
Appendix A.
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BILLING CODE 4163–18–P
Disease Control and Prevention, 4770
Buford Highway NE., MS F–59, Atlanta,
Georgia 30341–3717; phone: 800–323–
2132, 770–488–3141, or 954–356–6650;
email: vsp@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose and Background
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS) announces fees
for vessel sanitation inspections for
Fiscal Year (FY) 2016. These
inspections are conducted by HHS/
CDC’s Vessel Sanitation Program (VSP).
VSP helps the cruise line industry fulfill
its responsibility for developing and
implementing comprehensive sanitation
programs to minimize the risk for acute
gastroenteritis. Every vessel that has a
foreign itinerary and carries 13 or more
passengers is subject to twice-yearly
unannounced inspections and, when
necessary, reinspection.
DATES: These fees are effective October
1, 2015, through September 30, 2016.
FOR FURTHER INFORMATION CONTACT:
CAPT Jaret T. Ames, Chief, Vessel
Sanitation Program, National Center for
Environmental Health, Centers for
HHS/CDC established the Vessel
Sanitation Program (VSP) in the 1970s
as a cooperative activity with the cruise
ship industry. VSP helps the cruise ship
industry prevent and control the
introduction, transmission, and spread
of gastrointestinal illnesses on cruise
ships. VSP operates under the authority
of the Public Health Service Act
(Section 361 of the Public Health
Service Act; 42 U.S.C. 264, ‘‘Control of
Communicable Diseases’’). Regulations
found at 42 CFR 71.41 (Foreign
Quarantine—Requirements Upon
Arrival at U.S. Ports: Sanitary
Inspection; General Provisions) state
that carriers arriving at U.S. ports from
foreign areas are subject to sanitary
inspections to determine whether
rodent, insect, or other vermin
infestations exist, contaminated food or
water, or other sanitary conditions
requiring measures for the prevention of
the introduction, transmission, or
spread of communicable diseases are
present.
The fee schedule for sanitation
inspections of passenger cruise ships by
VSP was first published in the Federal
Register on November 24, 1987 (52 FR
45019). HHS/CDC began collecting fees
on March 1, 1988. This notice
announces fees that are effective for FY
2016, beginning on October 1, 2015,
through September 30, 2016.
The following formula will be used to
determine the fees:
Fee
Appendix A
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Fees for Sanitation Inspections of
Cruise Ships
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: General Notice.
SUMMARY:
The fee schedule (Appendix A) will
be effective October 1, 2015, through
September 30, 2016.
Applicability
Vessel size (GRT 1)
The fees will apply to all passenger
cruise vessels for which inspections are
conducted as part of HHS/CDC’s VSP.
Inspections and reinspections involve
the same procedures, require the same
amount of time, and are therefore
charged at the same rates.
PO 00000
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SIZE/COST FACTORS USED TO
DETERMINE INSPECTION FEES
Fmt 4703
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Extra Small (<3,001 GRT) ....
Small (3,001–15,000 GRT) ..
Medium (15,001–30,000
GRT) .................................
Large (30,001–60,000 GRT)
Extra Large (60,001–120,000
GRT) .................................
Mega (>120,001 GRT) .........
E:\FR\FM\26AUN1.SGM
26AUN1
Approximate
cost per
GRT 1
US$0.25
0.50
1.00
1.50
2.00
3.00
EN26AU15.000
rmajette on DSK7SPTVN1PROD with NOTICES
HHS/CDC retains a copy of each reporting
ART program’s annual data files. In addition
to the annual ART reports, the NASS
database is used to evaluate emerging ART
research questions and to monitor safety and
efficacy issues related to ART treatment for
improving maternal and child health
outcomes. ART data files are protected under
an Assurance of Confidentiality pursuant to
Section 308(d) of the Public Health Service
Act (42 U.S.C. 242[m]). This assurance allows
HHS/CDC programs to assure that certain
identifiable data collected on individuals and
institutions involved in research or nonresearch projects remain confidential.
Starting in 2013, researchers may analyze
ART surveillance data using the National
Center for Health Statistics’ (NCHS) Research
Data Center (RDC) under authorization of
Sections 304 and 306 of the Public Health
Service Act, 42 U.S.C.242(k) (See https://
www.cdc.gov/art/AccessData.html).
Researchers requesting access to the NASS
data files are subject to all RDC procedures
and protocols.
[FR Doc. 2015–21108 Filed 8–25–15; 8:45 am]
51819
Agencies
[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Notices]
[Pages 51811-51819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21108]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Reporting of Pregnancy Success Rates From Assisted Reproductive
Technology (ART) Programs
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (DHHS).
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) announces the
requirements for reporting of pregnancy success rates from assisted
reproductive technology (ART) programs as required by the Fertility
Clinic Success Rate and Certification Act of 1992 (FCSRCA). This notice
describes who shall report to HHS/CDC, the reporting system (National
ART Surveillance System (NASS); the process for reporting by each ART
program; the data to be reported; and the contents of the published
reports. The proposed changes to reporting requirements were published
in the Federal Register on July 21, 2014 (79 FR. 42328) and February
18, 2015 (80 FR. 8659) in accordance with requirements under the
Paperwork Reduction Act; public comments and recommendations were
requested. This notice incorporates the comments received from those
notices and supersedes the previous notice published in the Federal
Register, September 1, 2000 (65 FR. 53310).
FOR FURTHER INFORMATION CONTACT: Jeani Chang, Division of Reproductive
Health, National Center for Chronic Disease Prevention and Health
Promotion, Centers for Disease Control and Prevention, 4770 Buford
Highway, MS-74, Atlanta, Georgia 30341. Phone: (770) 488-6370. Email:
artinfo@cdc.gov.
SUPPLEMENTARY INFORMATION: Section 2(a) of Public Law 102-493 (42
U.S.C.263a-1(a)), the Fertility Clinic Success Rate and Certification
Act of 1992 (FCSRCA) requires that each ART program report annually to
the Secretary of the Department of Health and Human Services through
the Centers for Disease Control and Prevention (1) pregnancy success
rates achieved by such ART program and (2) the identity of each embryo
laboratory used by such ART program and whether the laboratory is
certified or has applied for such certification under the act.
FCSRCA defines ``assisted reproductive technology'' (ART) as ``all
treatments or procedures which include the handling of human oocytes or
embryos, including in vitro fertilization, gamete intrafallopian
transfer, zygote intrafallopian transfer, and such other specific
technologies as the Secretary may include in this definition, after
making public any proposed definition in such manner as to facilitate
comment from any person (including any federal or other public
agency).''
The Secretary is directed in FCSRCA to define pregnancy success
rates and ``make public any proposed definition in such a manner as to
facilitate comment from any person during its development.''
Section 2(c) (42 U.S.C. 263a-1(c)) states ``the Secretary shall
consult with appropriate consumer and professional organizations with
expertise in using, providing, and evaluating professional services and
embryo laboratories associated with assisted reproductive
technologies.''
Since 1995, HHS/CDC has reported pregnancy success rates of United
States ART programs as required by FCSRCA. Changes in ART practice
require
[[Page 51812]]
periodic revision of the National ART Surveillance System in order to
maintain accurate reporting of ART success rates. In updating the
definitions of success rates, as well as various factors and
characteristics required for calculating the success rates or that
might influence the success rates, HHS/CDC consulted with
representatives of the Society for Assisted Reproductive Technology
(SART, a national professional association of ART clinical programs),
the American Society for Reproductive Medicine (ASRM, a national
society dedicated to the advancement of the science and practice of
reproductive medicine), RESOLVE (the National Infertility Association,
a national, nonprofit consumer organization), Path2Parenthood (P2P, a
national, nonprofit consumer organization), and the American Urological
Association (AUA, a national professional association of urologic
community) as well as a variety of individuals with expertise and
interest in infertility and/or ART.
Public Comment Summary and Responses
Seven comments were received in response to the July 21, 2014 (79
FR. 42328) notice that outlined the reporting requirements, changes to
NASS data elements, and the associated burden. Comments are summarized
by the following topics: burden estimates, proposed NASS data elements,
duplicative data collection, and request for additional data elements.
Some commenters provide comments on multiple topics. Summaries of these
comments, as well as HHS/CDC's responses, are provided below.
1. Burden estimates: Four commenters expressed concern that
implementation of the new NASS system was not included in the total
burden estimates, thus the burden to clinics for data reporting was
underestimated.
Response: The estimated annual burden to clinics is calculated
using the average time required to answer the number of questions and
possible responses to each question when applicable. We acknowledge
that there is an additional burden for the first year of this
transition associated with making the appropriate software
modifications that was not represented in the notice published on July
21, 2014. In order to minimize the impact of this burden on clinic
operations, projected implementation of the new data collection system
was changed from January 1, 2015 to January 1, 2016. We have also
recalculated the burden for the first year to include the fixed burden
associated with changes to the data collection systems in each clinic.
The following changes were made to the burden estimate: a) increased
the average burden to 43 minutes per response and b) added a one-time
system implementation for each clinic (40 hours per each response) to
update their data collection systems to reflect the new platform and
interface of the NASS web-application over a 3-year clearance period.
2. Proposed NASS data elements: There was concern from one
commenter that the proposed data elements went beyond the mandate
established by FCSRCA and its implementing regulations. Commenter cited
the information related to the quality of any embryo considered for
transfer and prior ART cycles that resulted in pregnancy as two
examples that appear to go beyond the mandate.
Response: HHS/CDC thanks the commenter for this comment, but notes
that changes to the NASS data elements are essential to keep pace with
changes in medical practice, ensure that reported success rates reflect
standardized definitions, and provide additional insight into factors
that may affect success rates. Regarding the addition of variables such
as embryo quality and the number of prior ART cycles, the NASS system
collects information on ART outcomes as well as other patient and
procedure characteristics that may affect treatment outcomes. The
reporting of success rates by patient and procedural factors allows
consumers to see success rates for patients similar to themselves and
undergoing procedures with similar characteristics. Presenting success
rates without taking patient and procedural characteristics into
account could produce inaccurate rates.
3. Duplicative data collection: There was concern from one
commenter that the collection of ART outcomes by HHS/CDC duplicates the
work SART already does and the resulting cost of a duplicative data
collection to the government and taxpayers is not warranted.
Response: HHS/CDC notes the commenter's concern and reminds the
commenter that this data collection is mandated by statute while data
collection by a private entity is not required by law. FCSRCA requires
that each assisted reproductive technology (ART) program annually
report pregnancy success rates achieved by such ART program to the
Secretary through HHS/CDC. Changes in ART practice require periodic
revision of the National ART Surveillance System in order to maintain
accurate reporting of ART success rates.
4. Request for additional data elements: Three commenters suggested
the addition of data elements.
Commenter 1 suggested that it would be important for the NASS and
Assisted Reproductive Technology Team to consider adding variables
relating to infant outcomes (as listed below).
(1) Use of traditional or gestational surrogate carriers: Surrogate
age, number of prior pregnancies, number of previous live born infants,
and number of prior surrogacy (either gestational carrier or
traditional surrogate).
(2) Maternal variables: occurrence of pregnancy induced
hypertension, maternal diabetes and stage, hyperemesis gravidarium,
fetal ultrasound results with special focus on fetal echocardiogram at
20-24 weeks.
(3) Placental examination: placental abnormalities, evidence of
single umbilical artery, histologic chorioamnionitis, in twins or
multiple gestations presence of twin to twin transfusion syndrome
associated with artery-venous shunting in the placenta, placentation
(diamniontic-dichorionic, monochorionic-diamniontic, and placentation
of greater than twin).
(4) Neonatal Variables Suggested to be added:
A. Infant Weight, Length, and Head Circumference
B. Infant Gestational age as determined by Ballard Physical and
Neurodevelopment examination
C. Admission to Neonatal Intensive Care Unit
D. Specific Neonatal Variables:
1. Apgar Scores as 1 and 5 minutes, requirement for resuscitation,
2. NICU admission,
3. Length of Hospital Stay,
4. Time (in days) to regain birth weight,
5. Specific Neonatal Morbidities:
a. Occurrence of Respiratory Distress Syndrome,
b. Presence of patent ductus arterioles,
c. Hyperbilirubinemia requiring A) phototherapy and/or B)exchange
transfusion and maximum total serum bilirubin,
d. Occurrence of intraventricular hemorrhages by grade
(Papille)i.e. Grade I to IV,
e. Occurrence of periventricular leukomalacia,
f. Occurrence of necrotizing enterocolitis using the Bell scoring
system,
g. Occurrence of electrographic seizures,
h. Did the infant pass the newborn hearing screen,
i. Abnormalities on the Newborn Metabolic Screen,
[[Page 51813]]
j. Results of the screen for congenital heart disease (Upper and
Lower Sp02 after 24 hours),
k. Occurrence of minor and major phenotypic anomalies, occurrence
of specific syndromes including imprinting disorders,
l. Karyotype results (if performed), results of chromosomal arrays
(if performed).
Response: FCSRCA requires that each assisted reproductive
technology (ART) program annually report pregnancy success rates
achieved by such ART program to the Secretary through HHS/CDC. Many of
the suggested data elements are only available through vital records
(i.e. birth certificates, fetal death certificates) and NASS does not
collect information from birth certificates. Collection of the
additional variables suggested is not feasible as part of this effort.
No changes to the data collection were made as a result of this
comment.
Commenter 2 requested clarification if the following male
infertility data points are included in the new planned data
collection:
Medical condition
Genetic or chromosomal abnormality, Specify______
Abnormal sperm parameters (select all that apply)
Azoospermia, obstructive
Azoospermia, non-obstructive
Oligospermia, severe (<5 million/mL)
Oligospermia, moderate (5-15 million/mL)
Low motility (<40%)
Low morphology (4%)
Other male factor (not included above), Specify______
Response: The suggested male infertility data points are already in
the proposed NASS data elements; thus, no changes were made to the data
collection as a result of this comment.
Commenter 3 recommended adding the method of delivery (Vaginal or
C-section): Indication for c-section (if c-section used) (Prior c-
section, Overdue delivery, Medical complication, Non-medical
indication/Patient preference). This will take less than two additional
minutes per cycle with live birth (zero for cycles without birth), as
this information is almost always in the documents we routinely obtain.
Rationale for inclusion of this information includes: Some reports
indicate c-section delivery is more common with frozen-thawed embryo
transfer. It is also reported that frozen-thawed embryo transfer is
associated with larger birthweights. These two variables might be
causally related, or might be confounded in assessments of perinatal
outcomes. Consider that large infants can motivate a c-section, FET
cycles often follow a fresh delivery that might have used a c-section
and thus create an indication for c-section, and c-sections abbreviate
a pregnancy so that birth by c-section occurs some hours or days
earlier than otherwise would have.
Response: HHS/CDC appreciates the suggestion to add `Method of
Delivery' to the data collection and agrees that this information could
be reliably reported by the patient. `Method of Delivery (Vaginal or C-
section)' was added as a proposed data element. However, `Indication
for C-Section' is usually only available through either the birth
certificate or from the obstetrical care providers. Collecting
information directly from the obstetrician/gynecologists is not
feasible as part of this effort.
Appendix--Notice for the Reporting of Pregnancy Success Rates From
Assisted Reproductive Technology Programs
Introduction
This notice includes four sections:
I. Who Reports: describes who shall report to HHS/CDC.
II. When and How to Report: describes the reporting system and
process for reporting by each ART program.
III. What to Report: describes the data items and definitions to be
included in the reporting database.
IV. Published Reports and Data Usage: outlines the topics that will
be included in the annual published reports and describes how data
are collected in the reporting database.
I. Who Reports
The Fertility Clinic Success Rate and Certification Act of 1992
(FCSRCA) requires that each assisted reproductive technology (ART)
program shall annually report pregnancy success rates to the
Secretary of the Department of Health and Human Services through
HHS/CDC. HHS/CDC began collecting data from ART programs starting
with ART cycles performed in 1995. Between 1997 and 2003, HHS/CDC
contracted with the Society for Assisted Reproductive Technology
(SART) to annually obtain a copy of their clinic-specific database.
Since 2004, HHS/CDC has maintained the National ART Surveillance
System (NASS), a web-based ART data reporting system.
The following guidelines have been established to define an ART
program and the reporting responsibilities of an ART program,
including the responsibilities of each ART program's Medical
Director.
A. Criteria to be Considered an ART Program
An ART program is defined as a practice, program, or clinic if
it meets the following criteria:
(1) It is a legal business entity that practices under State
law;
(2) It is recognizable to the consumer as a stand-alone ART
program or clinic, separate and apart from another ART program or
clinic with whom that program may share some or all resources or
liability;
(3) It provides ART services to patients who have experienced
infertility or are undergoing ART for other reasons.
B. Reporting Responsibilities of the Medical Director
The current Medical Director of the ART program at the time of
the reporting is responsible for verifying and reporting all ART
cycle data for that reporting year. If the Medical Director is not
available to verify and approve the reported cycle data due to
unforeseen circumstances, the Laboratory Director may assume the
reporting responsibilities for the Medical Director. If there is a
change in personnel, including the Medical Director's position,
between the time the ART cycles occurred and the time the reporting
year data are due, the current Medical Director in position at the
time of the final reporting deadline is responsible for reporting
and verifying all ART cycles performed by that program in that
reporting year.
C. Reporting Responsibilities of ART Program
There are a variety of ways in which ART programs might be
structured. Reporting is based upon ART cycles performed within a
program not by an individual physician. Therefore, one or more
individual physicians within a single ART program may not report
their data separately from the remainder of the physician group.
Individual physicians who practice independently may not pool their
data and report together as one program.
The following sections provide guidance on the reporting
responsibilities for programs:
(1) One practice, one site--An ART program with one or more
physicians who share resources and/or liability, but not necessarily
patients, at one location. In a practice with several physicians,
the Medical Director is required to report every ART cycle performed
at the ART program under one NASS ID, even when other practitioners
in the ART program may have performed most or all of the work for
the cycle(s). An ART program cannot report cycles from another
program for which one of their current or former practice physicians
are responsible except in the case of reorganization. Reorganization
of an ART program is defined as a change in ownership or
affiliation, or when at least two of the three key staff positions
(Practice Director, Medical Director, or Laboratory Director) change
because the person(s) in those positions is/are no longer employed
with the practice. In the case of reorganization, the clinic Medical
Director in position at the time of the final reporting deadline is
responsible for reporting and verifying all ART cycles performed by
that program in that reporting year.
(2) One practice, multiple sites--An ART program with one or
more physicians who share resources and/or liability, but not
necessarily patients, at multiple locations. If any site satisfies
the definition of an individual ART program as described above
(Section I, A), that site should report
[[Page 51814]]
separately under a unique NASS ID. Contact the NASS Help Desk at 1-
888-650-0822 to discuss other multiple site scenarios. A reporting
determination will be made based on the definitions and guidance
provided here.
(3) Multiple ART programs involved in one cycle--Different ART
programs responsible for ovarian stimulation, oocyte retrieval, and/
or embryo transfer.
The following guidelines should be used:
a. The requirement to report cycles lies with the ART program
that accepts responsibility for the embryo culture. The ART programs
involved must have a method in place to ensure that these cycles can
be prospectively reported by the ART program required to report
them. In addition, all canceled cycles must be reported by the ART
program accepting responsibility for the embryo culture.
b. Cycles involving previously cryopreserved oocytes/embryos are
to be reported by the ART program that accepts responsibility for
thawing the oocytes/embryos.
(4) Multiple ART programs sharing one ART laboratory--
Independent ART programs that share an embryology laboratory or use
another program's laboratory must report their cycles independently
under their own unique NASS IDs.
II. When and How To Report
A. Reporting Activities
The deadline for reporting ART cycle and pregnancy outcome data
to HHS/CDC is December 15 of the year after which cycles were
conducted. For example, the deadline to report data on cycles
initiated between January 1, 2013 and December 31, 2013 was December
15, 2014. HHS/CDC will send a letter to all qualifying ART programs
to announce each reporting year deadline 90 days before cycle data
are due. An ART program is considered to be non-compliant with the
federal reporting requirements of the FCSRCA if the program was in
operation at any time during the reporting year and performed any
ART cycles and (a) fails to submit ART cycle data to HHS/CDC by the
reporting deadline, or (b) the program's Medical Director fails to
verify the clinic success rates table by the reporting deadline.
These programs will be identified as non-reporters in HHS/CDC's
annual Assisted Reproductive Technology Fertility Clinic Success
Rates Report. ART programs that were in operation at any time during
the reporting year but did not perform any ART cycles will not be
included in HHS/CDC's annual ART report (either as a reporting or as
a non-reporting clinic).
ART programs that are submitting data to HHS/CDC via the NASS or
through an approved alternative (i.e., SART member clinics may
report their data to NASS through SART) will be considered to be in
compliance with federal reporting requirements of the FCSRCA.
Regardless of the method chosen for submitting data to NASS, each
clinic must complete the annual submission steps as detailed in the
NASS Annual Submission Guide posted on the NASS Web site
(www.artreporting.org). A NASS account can be set up by calling the
NASS Help Desk at 1-888-650-0822 or by sending an email to
NASS@artreporting.org. NASS accounts established previously can be
used for data submission by the same clinic, although user passwords
may need to be re-established if they have expired since last using
NASS. ART programs should also notify the NASS Help Desk of any
changes in clinic location, ownership, or key staff (i.e., Practice,
Medical, or Laboratory Director) and provide NASS with a list of all
practicing physicians in the program.
All cycle data must be reported prospectively, i.e., reporting
of initial cycle intent and select patient details is required
within four days of cycle initiation. Each ART patient will be
assigned a unique, system-generated patient ID when the program
first enters the patient in NASS. The program is responsible for
linking each patient's ID to the patient's medical records for
reporting any future ART cycles. Each ART cycle for each patient is
also assigned a unique cycle code. In NASS, the patient is
identified by the NASS ID and the patient ID; the cycle code (cycle
IDs) allows identification of all cycles performed on a single
patient. Since the patient's name and social security number are not
included in the reporting database, each program should maintain
personal identifiers in the program's database on site in order to
link every cycle reported to CDC to a specific patient.
B. Updating of Reporting Requirements
ART is a rapidly developing medical science. To keep current as
practices evolve, ART reporting requirements, including data
collection instruments, variables, and definitions, will be
periodically reviewed and updated as new knowledge concerning ART
methods and techniques becomes available. During such a review,
professional and consumer groups and individuals will be consulted
to confirm the validity of the new or revised reporting requirements
and data elements. Clinics will be notified in writing at least 120
days in advance of January 1st of the reporting year of all changes
to the reporting requirements.
ART programs are ultimately responsible for ensuring that their
data are mapped accurately into the required NASS format if using
third-party electronic medical records or reporting systems to
submit their ART data through NASS to HHS/CDC. ART programs must
ensure their clinic data can be correctly transmitted to NASS for
pre-import NASS quality control reviews and imported into NASS in
time for the required NASS annual submission steps by the HHS/CDC
deadline. HHS/CDC will continue to inform clinics of all necessary
requirements for importing data from other electronic medical record
systems into NASS and for checking imported data to ensure that it
retains the accuracy and compatibility of the data entry system from
which it was extracted.
Each ART program should be aware that the Paperwork Reduction
Act is applicable to this data collection. Under the Paperwork
Reduction Act of 1995, a Federal agency shall not conduct or sponsor
a collection of information from ten or more persons other than
Federal employees, unless the agency has obtained approval from the
Office of Management and Budget (OMB) for the collection of
information. A person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.
In compliance with the Paperwork Reduction Act, HHS/CDC has obtained
OMB approval to collect this data under OMB control No. 0920-0556,
expiration 07/31/2018.
C. External Validation of Clinic Data
As part of the annual routine activities of this surveillance
program, all ART programs are subject to external validation of
their reporting activities, which will include review by appropriate
professionals from CDC staff and CDC contractors. This review may
include but is not limited to examination of medical and laboratory
records and comparison with data reported in NASS.
Each year, HHS/CDC selects a random sample of 5-10% of all
reporting ART programs, after taking into consideration some clinic
characteristics, e.g., size of clinics, number of cancelled cycles,
or number of multiple births for an on-site validation visit. The
purpose of validation is to evaluate the overall accuracy of data
reported in NASS. It also serves to identify any systematic problems
that could cause data collection to be inconsistent or incomplete.
During validation visits, data submitted to NASS are compared with
data recorded in the patient medical records, which allows for the
calculation of discrepancy rates. All potential data discrepancies
identified during the on-site visit will be discussed with staff of
the ART program. If major data discrepancies are identified during
data validation (e.g., lack of supporting information for pregnancy
outcomes, underreporting cycles, etc.), HHS/CDC may re-select these
ART programs for data validation during the following reporting
year(s) to assess corrections of identified data errors. Aggregate
findings for validated data fields from all ART programs
participating in validation will be reported in HHS/CDC's Fertility
Clinic Success Rates Report. The HHS/CDC validation process is not
an assessment of clinical practice or overall record keeping;
however, the results of the validation may be helpful to ART
programs.
Each clinic is responsible for maintaining appropriate medical
and laboratory records that contain information reported in NASS.
This information must be able to link each patient, cycle, oocyte
retrieved, transfer, and pregnancy outcome for the purpose of
external validation.
III. What To Report
Cycle-specific data for the following patients must be reported:
(1) All patients undergoing ART, (2) all patients undergoing ovarian
stimulation or monitoring with the intent of undergoing ART but who
did not proceed to oocyte retrieval or transfer of embryos for any
reason, including patients whose cycles were canceled for any
reason, (3) all patients providing donor oocytes, and (4) all
patients undergoing monitoring and/or embryo (or oocyte) thawing
with the
[[Page 51815]]
intention of transferring cryopreserved embryos. Only cycles
performed in the U.S. may be reported to CDC. ART programs must
report the following data items:
A. Patient Demographic Information
Date of Cycle Reporting
NASS ID
Optional Identifier (as needed)
Date of Birth
Gender
U.S. Residency
City of Residence
State of Residence
Country of Residence (if not United States)
B. Cycle Information
1. Intended Cycle Information
Intended Type of Cycle (IVF, GIFT, ZIFT, Oocyte or embryo banking)
Intended Embryo Source (Patient, Donor)
Intended Embryo State (Fresh, Frozen)
Intended Oocyte Source (Patient, Donor)
Intended Oocyte State (Fresh, Frozen)
Intended Sperm Source (Partner, Donor, Patient, Unknown)
Pregnancy Carrier (Patient, gestational carrier, none-for oocyte/
embryo banking only)
2. Cycle Information
Type of Cycle (IVF, GIFT, ZIFT, Oocyte or embryo banking)
Embryo Source (Patient, Donor)
Embryo State (Fresh, Frozen)
Oocyte Source (Patient, Donor)
Oocyte State (Fresh, Frozen)
3. Patient Medical Evaluation
Reason(s) for ART
Male Infertility (Medical condition, Genetic or chromosomal
abnormality, abnormal sperm parameters, Obstructive azoospermia,
Non-obstructive azoospermia, Severe oligospermia, Moderate
oligospermia, Low motility, Low morphology, other)
History of Endometriosis
Tubal Ligation for Contraception
Current or Prior Hydrosalpinx
Other Tubal Disease (Not Current or Historic Hydrosalpinx)
Ovulatory Disorders (PCO, Other)
Diminished Ovarian Reserve
Uterine Factor
Preimplantation Genetic Diagnosis as Primary Reason for ART
Oocyte or Embryo Banking As Reason for ART
Indication for Use of Gestational Carrier (Absence of uterus,
Significant uterine anomaly, Medical contraindication to pregnancy,
Recurrent pregnancy loss, Unknown)
Recurrent Pregnancy Loss
Other Reasons Related to Infertility (Specify)
Other Reasons Not Related to Infertility (Specify)
Unexplained Infertility
C. Patient History
Height
Weight
History of Smoking
History of Prior Pregnancy (Number of prior full term, preterm,
stillbirth, spontaneous, ectopic pregnancies)
Months attempting pregnancy
History of Prior ART (Fresh & Frozen)
Maximum FSH Level (mIU/mL)
Recent AMH Level (ng/mL)
Date of Most recent AMH Level
D. Oocyte Source and Carrier Information
Date of Birth
Race (White, Black, Asian, Native Hawaiian/Pacific Islander,
American Indian or Alaska Native)
Ethnicity (Hispanic, non-Hispanic, Refused, Unknown)
E. Sperm Source Information
Date of Birth
Race (White, Black, Asian, Native Hawaiian/Pacific Islander,
American Indian or Alaska Native)
Ethnicity (Hispanic, non-Hispanic, Refused, Unknown)
F. Stimulation and Retrieval
Stimulation
Aromatase Inhibitor/Estrogen Receptor Medication (Clomiphene and
Letrozole dosage)
FSH Medication
LH/HCG Medication
GnRH (Gonadotropin-releasing hormone)(None, GnRH agonist
suppression, GnRH agonist flare, GnRH Antagonist suppression)
Canceled Cycle
Date of Canceled Cycle
Reason for Canceled Cycle (Low ovarian response, High ovarian
response, Inadequate endometrial response, Concurrent illness,
Withdrawal for personal reasons, Other)
Date of Retrieval
Number of Patient Oocytes Retrieved
Number of Donor Oocytes Retrieved
Use of Oocytes (For this cycle, Oocytes frozen for future use,
Oocytes shared with other patients, Embryos frozen for future use)
Complications of Stimulation and Retrieval (Infection, Hemorrhage,
Ovarian Hyperstimulation requiring intervention or hospitalization,
Medication Side Effect, Anesthetic Complication, Thrombosis, Death,
Other) Sperm Status (Fresh, Thawed, Mix of fresh and thawed) Sperm
Source Utilized (Ejaculated, Epididymal, Testis, Electroejaculation,
Retrograde urine, Donor, Unknown)
G. Laboratory Information
ICSI (Intracytoplasmic sperm injection) (All oocytes, Some oocytes,
No oocytes, Unknown)
Indication for ICSI (Prior failed fertilization, Poor fertilization,
PGD, Abnormal semen parameters, Low oocyte yield, Laboratory
routine, Frozen cycle, Rescue ICSI, Other)
IVM (In vitro maturation)
PGD (Pre-implantation genetic diagnosis)
PGS (Pre-implantation genetic screening)
Reasons for PGD/PGS
Technique(s) Used for PGD/PGS
Assisted Hatching
2 Pronuclei
Research Cycle
SART Approval Code for Research Cycle
H. Transfer Information
Attempted Transfer
Reason for No Transfer (Low Ovarian Response, High Ovarian Response,
Failure to Survive Thaw, Inadequate Endometrial Response, Concurrent
Illness, Patient Withdrawal from Treatment, Unable to Obtain Sperm
Specimen, Insufficient Embryos, Other)
Date of Transfer
Endometrial Thickness
1. Fresh Embryo Transfer
Number of Fresh Embryos Available for Transfer
Number of Fresh Embryos Transferred
eSET
Quality of Embryo (Good, Fair, Poor, Unknown)
Number of Fresh Embryos Cryopreserved
2. Thawed Embryo Transfer
Number of Thawed Embryos Available for Transfer
Number of Thawed Embryos Transferred
Quality of Embryo
Date of Oocyte retrieved for the Thawed Embryos
Number of Thawed Embryos Cryopreserved
3. GIFT/ZIFT/TET Transfer (for Non-IVF Cycle)
Number of Oocytes/Embryos Transferred to Fallopian Tube
I. Outcome Information
Outcome of Treatment (Not Pregnant, Biochemical Pregnancy, Ectopic
Pregnancy, Clinical Intrauterine Gestation, Heterotopic Pregnancy,
Unknown)
Maximum Number of Fetal Hearts
Ultrasound Date
If >2 Fetal Hearts, any Monochorionic Twins/Multiples
Outcome of Pregnancy (Live Birth, Stillbirth, Spontaneous Abortion,
Induced Abortion, Maternal Death Prior to Birth, Unknown)
Date of Pregnancy Outcome
Method of delivery (Vaginal, Cesarean section)
Source for Outcome of Pregnancy (Verbal Confirmation Patient,
Written Confirmation Patient, Verbal Confirmation Physician or
Hospital, Written Confirmation Physician or Hospital)
Method of Delivery (Vaginal, Cesarean section)
Number of Infants Born
Birth Status (Live Birth, Stillbirth, Unknown)
Gender of Infant (Each Live-born and Stillborn Infant)
Birth Weight (Each Live-born and Stillborn Infant)
Birth Defect (Each Live-born and Stillborn Infant) (Genetic Defect/
Chromosomal Abnormality, Cleft Lip or Palate, Neural Tube Defect,
Cardiac Defect, Limb Defect, Other Defect)
J. Definitions
The following definitions provide clarification for the required
data items:
[[Page 51816]]
Assisted reproductive technology (ART)--All treatments or
procedures that include the handling of human oocytes or embryos for
the purpose of establishing a pregnancy. This includes, but is not
limited to in vitro fertilization and transcervical embryo transfer,
gamete intrafallopian transfer, zygote intrafallopian transfer,
tubal embryo transfer, oocyte or embryo cryopreservation, oocyte or
embryo donation, and gestational surrogacy. ART does not include
assisted insemination using sperm from either a woman's partner or
sperm donor.
ART cycle--ART cycles can be stimulated (use of ovulation
induction) or unstimulated (natural cycle). An ART cycle is
considered any cycle in which (1) ART has been used, (2) the woman
has undergone ovarian stimulation or monitoring (i.e., performance
of sonogram, serum estradiol or LH measurements) with the intent of
undergoing ART, (3) in the case of donor oocytes, a woman began
medication for endometrial preparation with the intent of undergoing
ART, or (4) in the case of cryopreserved embryos or oocytes, a woman
began medication for endometrial preparation with the intent of
undergoing ART and/or embryos were thawed with the intent of
transfer.
Anti-mullerian hormone (AMH) level--A measure of diminished
ovarian reserve that predicts the ovaries' response to ovarian
stimulation during ART.
Assisted hatching--A micromanipulation technique that involves
making a small opening in the zona wall of the embryo in an effort
to enhance implantation.
Azoospermia, obstructive--Complete absence of sperm from the
ejaculate. Obstructive azoospermia may result from epididymal,
vasal, or ejaculatory duct pathology.
Azoospermia, non-obstructive--Complete absence of sperm in the
ejaculate due to testicular failure, varicoceles, or chromosomal
abnormalities such as Y-chromosome microdeletions or karyotypic
abnormalities (e.g., Klinefelter syndrome).
Birth defect--Anomaly diagnosed prior to or at birth that
results in death or causes a serious disability requiring surgical
and/or medical therapy. Specific anomalies to be identified include
genetic defect/chromosomal abnormality, cleft lip or palate, neural
tube defect, cardiac defect, limb defect, or other defect.
Biochemical pregnancy--A positive serum pregnancy test (Beta-
hCG) without ultrasound confirmation of a gestational sac within the
uterus, and without diagnosis of an ectopic pregnancy.
Blastocyst/trophectoderm biopsy--Procedure involving the removal
of a small number of trophectoderm cells from a blastocyst stage
embryo for genetic testing. A blastocyst is a day 5/6 embryo which
contains two cell types--the inner cell mass, which eventually
develops into fetal tissues, and the trophectoderm, which gives rise
to the developing placenta and other tissues.
Blastomere biopsy--Procedure involving the removal of one
blastomere from a cleavage stage embryo for genetic testing. A
cleavage stage embryo is a day 3 embryo when approximately 6-8 cells
are present.
Cancelled cycle--An ART cycle in which ovarian stimulation or
monitoring or endometrial preparation has been carried out with the
intent of undergoing ART but which did not proceed to oocyte
retrieval or to the transfer of embryos. Reasons for cancellation
include low ovarian response, high ovarian response, inadequate
endometrial response, concurrent illness, patient withdrawal from
treatment, failure of oocytes to survive thaw, an inability to
obtain sperm specimen, or insufficient embryos.
Clinical pregnancy/Clinical intrauterine gestation--An
ultrasound-confirmed gestational sac within the uterus or the
documented occurrence of a birth, spontaneous abortion, or induced
abortion in cases of missing ultrasound data. Clinical pregnancies
include all gestational sacs regardless of whether or not a
heartbeat is observed or a fetal pole is established. This
definition excludes ectopic pregnancy but includes pregnancies which
end in live birth, stillbirth, spontaneous abortions, and induced
abortions.
Clomiphene citrate--An ovulation induction medication with trade
names such as Clomid[supreg], Serophene[supreg], or
Milophene[supreg].
Complication--A medical complication for the woman related to
ART procedures. Specific complications to be identified include
infection, hemorrhage requiring transfusion, ovarian
hyperstimulation syndrome requiring intervention or hospitalization,
medication side effect, anesthetic complication, thrombosis, death
of patient, or other specified complication.
Cryopreservation--A technique used in ART to preserve sperm,
oocytes, and embryos through freezing.
Cycle start date (cycle initiation date)--
(1) For fresh embryo, (both donor and non-donor): The first day
that medication to stimulate follicular development is given in a
stimulated cycle or the first day of menses in an unstimulated
cycle. For example:
a. The first day of gonadotropins in a gonadotropin only cycle
or in a long suppression GnRH agonist-gonadotropin cycle;
b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
d. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(2) For fresh embryo donor cycles:
a. The first day exogenous sex steroids are given to patient to
prepare the endometrium;
b. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(3) For frozen embryo cycles (both donor and non-donor):
a. The first day exogenous sex steroids are given to prepare the
endometrium;
b. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
(4) For oocyte/embryo banking cycles:
a. The first day of gonadotropins in a gonadotropin only cycle
or in a long suppression GnRH agonist-gonadotropin cycle;
b. The first day of GnRH agonist in a GnRH agonist flare-
gonadotropin cycle;
c. The first day of clomiphene or letrozole in a clomiphene/
gonadotropin cycle or a clomiphene only cycle;
d. The first day of natural menses or withdrawal bleeding in an
unstimulated cycle.
Diminished ovarian reserve--A condition of reduced fecundity
related to diminished ovarian function based on clinical assessment;
often indicated by FSH>10 mIU/mL or AMH<1.0 ng/mL.
Donor embryo cycle--A cycle initiated with the intent to
transfer donated embryos, that is, embryos derived from oocytes
previously fertilized for another couple's ART therapy that were
subsequently donated.
Donor oocyte cycle--A cycle initiated with the intent to
transfer oocytes, or embryos derived from oocytes that were
retrieved from a woman serving as an oocyte donor (sperm source may
be either the patient's partner or a sperm donor selected by the
patient).
Ectopic pregnancy--A pregnancy in which the fertilized egg
implants outside the uterine cavity.
Elective single embryo transfer--A procedure in which one
embryo, selected from a larger number of available embryos, is
placed in the uterus or fallopian tube. The embryo selected for eSET
might be from a previous IVF cycle (i.e.; cryopreserved [frozen]
embryos) or from a current fresh IVF cycle that yielded more than
one embryo. The remaining embryos may be set aside for future use
through cryopreservation.
Embryo--The normally (2 pronuclei) fertilized egg that has
undergone one or more divisions.
Embryo banking cycle--A cycle initiated with the intent of
cryopreserving all embryos for later use. (This does not apply to
cycles initiated with the intent to transfer embryos but for which
all embryos were subsequently cryopreserved regardless of the
reason.) Embryo banking can be short term (<12 months) or long term
(>=12 months).
Embryo quality--Refers to the quality of the embryo as
determined by its morphology. Embryo morphology assessment includes
two parts: an overall grade and the stage. Overall grading is a
subjective assessment of the overall quality of the embryo as good,
fair or poor, and is based on assessment of certain characteristics
of the embryo, such as fragmentation, symmetry, inner cell mass
(ICM) quality or trophectoderm quality. Stage dependent grading
involves determining the developmental stage of the embryo.
--Good: Embryo free of imperfections or with only minor
imperfections.
--Fair: Embryo lacking exceptional quality but not excessively
imperfect either.
--Poor: Embryo with numerous imperfections.
Embryo transfer--Attempt to introduce embryo(s) into a woman's
uterus or attempt to introduce embryos or gametes (oocytes and
sperm) into a woman's fallopian tubes; a transfer procedure is
considered to have been carried out, if attempted, even if no
embryos or gametes were successfully transferred.
Endometriosis--The presence of tissue resembling endometrium in
locations outside the uterus such as the ovaries, fallopian
[[Page 51817]]
tubes, and abdominal cavity; a history of all stages of
endometriosis (minimal to severe) whether treated or not may be a
reason for ART.
Endometrium--The lining of the uterus that is shed each month as
the menstrual period. As the monthly cycle progresses, the
endometrium thickens and thus provides a nourishing site for the
implantation of a fertilized egg.
Fertilization--The penetration of the egg by the sperm and
fusion of genetic materials to result in the development of a
fertilized egg (or zygote).
Fetus--The developmental stage during pregnancy from the
completion of embryonic development at eight weeks of gestation
until delivery.
Flare protocol--A stimulation protocol in which a GnRH agonist
is started on day 2 of the same menstrual cycle during which the
eggs will be retrieved.
Follicle--A fluid-filled sac located just beneath the surface of
the ovary that contains an oocyte and cells that produce hormones.
Fresh embryo--An embryo created during the current cycle (either
from the patient or donor), i.e., not a thawed embryo created during
a previous cycle. Fresh embryos can be created from either fresh or
frozen eggs or sperm.
Fresh oocyte--An oocyte retrieved during the current cycle
(either from the patient or donor), i.e., not a thawed oocyte
retrieved during a previous cycle.
Follicle stimulating hormone (FSH)--A gonadotropin hormone
produced and released from the pituitary that stimulates the ovary
to ripen a follicle for ovulation. FSH is available in several types
of preparations including: Urofollitropin, Follitropin alfa and
Follitropin beta, some of which also include luteinizing hormone
(LH). Trade names include Gonal-f[supreg], Metrodin[supreg],
FertinexTM, BravelleTM, Repronex[supreg],
Pergonal[supreg], Humegon[supreg], and FollistimTM.
Full-term birth--A birth that reached 37 completed weeks of
gestation. This includes both live births and stillbirths. For the
purpose of reporting prior full-term births, births are counted as
birth events (e.g., a triplet birth is counted as one).
Gamete intrafallopian transfer (GIFT)--An ART procedure that
involves removing oocytes from a woman's ovary, combining them with
sperm, and immediately transferring (via a catheter) the eggs and
sperm into the fallopian tube. Fertilization takes place inside the
fallopian tube.
Gestational carrier (sometimes referred to as a gestational
surrogate)--A woman who gestates an embryo that did not develop from
her oocyte, with the expectation of returning the infant to its
intended parent(s). NOTE: For female same sex couples, the woman who
will carry the pregnancy should be identified as the patient and a
separate cycle should be reported if donor oocytes are used, even if
the patient's partner is the source of the oocytes. If a gestational
carrier is used, one cycle is reported for fresh embryo cycle; two
cycles should be reported for frozen embryo cycle (one for the
oocyte retrieval and one for the embryo transfer).
Gonadotropin--Hormones having a stimulating effect on the gonads
(ovaries and testes). Two such hormones are secreted by the anterior
pituitary: follicle stimulating hormone (FSH) and luteinizing
hormone (LH). Gonadotropins (FSH, either alone or with LH) are also
included in drug preparations used to stimulate follicular
development during an ART cycle.
Gonadotropin-releasing hormone (GnRH)--A hormone secreted by the
hypothalamus which induces the pituitary gland to release follicle
stimulating hormone (FSH) and luteinizing hormone (LH) into the
bloodstream.
--GnRH agonists--synthetic hormones that stimulate and then suppress
the secretion of FSH and LH
--GnRH antagonists--synthetic hormones that suppress the secretion
of FSH and LH
Gravidity--Total number of prior pregnancies a patient has had. This
includes ectopic pregnancies, biochemical pregnancies, and
pregnancies that ended in therapeutic abortion, spontaneous
abortion, stillbirth, or live birth.
Heterotopic pregnancy--A clinical intrauterine gestation in
combination with an ectopic pregnancy.
Human chorionic gonadotropin (HCG)--A hormone produced by the
placenta after implantation. It is used during ART to cause
ovulation.
Hydrosalpinx (current and prior)--Accumulation of watery fluid
in a fallopian tube that usually results from damage to the tube.
--Communicating: Patent fallopian tube. Non-occluded.
--Occluded: Non-communicating fallopian tube. Occlusion may be by
means of salpingectomy, tubal ligation, or hysteroscopic occlusion.
Induced abortion--Operative or medical intervention to
electively terminate the entire pregnancy (no gestational age
limit).
Intracytoplasmic sperm injection (ICSI)--The placement of a
single sperm into the ooplasm of an oocyte by micro-operative
techniques.
In vitro fertilization (IVF)--A method of assisted reproduction
that involves removing oocytes from a woman's ovaries, combining
them with sperm in the laboratory, and after fertilization is
confirmed, replacing the resulting embryo into the woman's uterus.
In vitro maturation (IVM)--Procedure in which eggs are removed
from the ovaries and are collected when they are still immature.
They are then matured in the laboratory before being fertilized.
Letrozole-- An ovulation induction medication, such as the
medication with the trade name Femara [supreg].
Live birth--A birth (delivery) in which at least one fetus was
live born, i.e., showed signs of life after the complete expulsion
or extraction from its mother or gestational carrier. Signs of life
include breathing, beating of the heart, pulsation of the umbilical
cord, or definite movement of the voluntary muscles. Any birth event
in which an infant shows signs of life should be counted as a live
birth, regardless of gestational age at birth. Live births are
counted as birth events (e.g., a triplet live birth is counted as
one).
Low sperm motility--Sperm motility less than laboratory norm
(varies by method used).
Low sperm morphology--Sperm morphology less than laboratory norm
(varies by method used).
Luteinizing hormone (LH)--A gonadotropin hormone produced and
released from the pituitary that stimulates the ovary to ripen a
follicle for ovulation.
Male infertility--Infertility due to abnormal semen parameters
or abnormal sperm function.
Method of delivery--Method used to deliver infant(s), vaginal or
Cesarean section.
Monochorionic--When two or more embryos or fetuses share the
same chorion and the same placenta.
NASS ID--An identification number assigned to each ART clinical
program by the reporting database operator.
Oligospermia--Semen with a low concentration of sperm. Severe
oligospermia is defined by <5 million spermatozoa per mL; moderate
is defined by 5-15 million spermatozoa per ml.
Oocyte--The female reproductive cell, also called an egg.
Oocyte banking--A cycle initiated with the intent of
cryopreserving all un-fertilized oocytes for later use. This does
not apply to cycles initiated with the intent to transfer embryos.
Oocyte banking can be short term (<12 months) or long term (>=12
months).
--Autologous oocyte banking--refers to cycles where the patient is
banking her own oocytes for later use.
--Donor oocyte banking--refers to cycles where a donor is banking
oocytes for use by someone else at a later date.
Oocyte donor--A woman who undergoes an oocyte retrieval
procedure with the intent of donating the oocytes retrieved to a
couple(s) undergoing an ART donor oocyte cycle (see donor oocyte
cycle).
Oocyte retrieval--A procedure to collect the eggs contained
within the ovarian follicles. This definition includes procedures in
which oocyte recovery was attempted but not successful.
Oocyte transfer--In GIFT (see definition), transfer of retrieved
eggs into a woman's fallopian tubes. Includes attempted transfers,
whether or not the transfer was successful.
Ovarian monitoring--Monitoring the development of ovarian
follicles by ultrasound and/or blood or urine tests.
Ovarian stimulation--Use of one or more follicle stimulation
medications to stimulate the ovary to develop follicles and oocytes.
Ovarian hyperstimulation requiring intervention or
hospitalization-- Hyperstimulation may be evidenced by abdominal
distension and discomfort; nausea, vomiting, and/or diarrhea;
ovaries enlarged 5-12 cm; ultrasonic evidence of ascites; clinical
evidence of ascites and/or hydrothorax or breathing difficulties;
change in blood volume; increased blood viscosity due to
hemoconcentration; coagulation abnormalities; diminished renal
perfusion and function, -hematocrit >50%; and requiring intervention
such as paracentesis or hospitalization.
Ovulatory disorder--One or more disorders causing reduced
fecundity that is associated
[[Page 51818]]
with structural, anatomic, or functional impairment of one or both
ovaries; includes polycystic ovary syndrome (PCOS), oligo-ovulation
(<=6 cycles per year), and anovulation (of hypothalamic or non-
hypothalamic causes) such as functional hypothalamic amenorrhea
(FHA).
Ovulation induction--See stimulated cycle.
Patient--Generally defined as the female undergoing treatment.
More specifically:
--For heterosexual couples, the patient is always the female
partner.
--For male same-sex couples, the male providing sperm is the
patient. If both male partners or neither male partner is providing
sperm, select one male to identify as the patient.
--For female same-sex couples, the patient is the female intending
to carry the pregnancy. If neither female intends to carry the
pregnancy (i.e. a gestational carrier will be used) the patient is
the female providing the oocyte. If both females are providing
oocytes, the patient is the youngest female providing oocytes. If
neither female intends to carry the pregnancy or provide oocytes
(i.e. donor oocytes are used with a gestational carrier), select one
female to identify as the patient.
Pituitary--A small gland just beneath the hypothalamus in the
brain which controls other hormone producing glands such as the
ovaries, thyroid, and adrenal glands. Ovarian function is controlled
through the secretion of follicle stimulating hormone (FSH) and
luteinizing hormone (LH) from the pituitary.
Polar body biopsy--Polar bodies are the by-products of egg
division. These cells do not serve any role for the egg or embryo
and will naturally degrade; however, they can be removed and tested
to determine the genetic status of the egg. Polar body testing only
tests for the maternal genetic contribution to the embryo. Polar
body biopsy occurs at the day 0 and/or day 1 stage. Both polar
bodies must be removed and tested in order to make an accurate
diagnosis.
Pregnancy test--A blood test that determines the level of human
chorionic gonadotropin (hCG), a hormone produced by the placenta; if
it is elevated, this confirms a pregnancy, which may be biochemical
only, ectopic, or clinical intrauterine gestation (normally
developing pregnancy).
Preimplantation genetic diagnosis (PGD)--Characterization of a
cell or cells from pre-implanted embryos from IVF cycles to
determine the presence or absence of a specific genetic defect.
Preimplantation genetic screening (PGS)--Characterization of a
cell or cells from pre-implanted embryos from IVF cycles to identify
genetic abnormalities.
Preterm birth--Birth at least 20 but less than 37 completed
weeks of gestation. This includes both live births and stillbirths.
For the purposes of reporting prior preterm births, births are
counted as birth events (e.g. a triplet birth is counted as one).
Recipient--In an ART cycle, the woman in whom embryos or oocytes
are transferred; includes the female patient or a gestational
carrier for the patient.
Recurrent pregnancy loss--A disease distinct from infertility,
defined by two or more failed pregnancies.
Semen--Fluid discharged at ejaculation in male.
Sperm--The male reproductive cell that has completed the process
of meiosis and morphological differentiation. Sperm used for ART can
be obtained using different methods:
--Ejaculation--Sperm is collected from a semen sample obtained by
ejaculation, the release of semen from the penis during orgasm.
--Electroejaculation--This procedure is used in men who have a
neurologic ejaculatory disorder, such as spinal cord injury or
psychogenic anejaculation, without mechanical obstruction of the
excurrent ductal system. This procedure involves the use of
electricity to directly stimulate the ejaculatory organs.
--Epididymal aspiration--A technique in which sperm is aspirated and
sampled percutaneously from the epididymis.
--Retrograde ejaculation--Ejaculation in which semen travels up the
urethra towards the bladder instead of to the outside of the body.
Sperm can be collected directly from the bladder or from voided
urine.
--Testicular biopsy--Sperm are obtained from a biopsy of
seminiferous tubules.
Sperm donor--A man providing sperm for the fertilization of
oocytes of a woman other than his sexual partner.
Spontaneous abortion (miscarriage)--A clinical pregnancy ending
in spontaneous loss of the entire pregnancy prior to completion of
20 weeks of gestation (or 18 weeks from the date of transfer if the
pregnancy was achieved using ART).
Stillbirth--Birth (delivery) at 20 weeks of gestation or later
(or 18 weeks or later from the date of transfer if the pregnancy was
achieved using ART) in which no fetus showed signs of life after the
complete expulsion or extraction from the mother. Stillbirths are
counted as birth events (e.g. a triplet stillbirth is counted as
one).
Stimulated cycle--An ART cycle in which a woman receives
medication to stimulate follicular development including the use of
clomiphene citrate, follicle stimulating hormone (FSH), or follicle
stimulating hormone and luteinizing hormone (FSH and LH).
Surgical sterilization--An operative procedure for the purpose
of termination of fertility. Surgical sterilization includes tubal
ligation, salpingectomy,vasectomy and hysterectomy.
Thawed oocyte--Oocyte retrieved during a previous cycle,
cryopreserved, and then thawed for use during the current cycle
(either from the patient or donor), i.e., not a fresh oocyte
retrieved during the current cycle.
Thawed embryo--Embryo created during a previous cycle,
cryopreserved, and then thawed for use during the current cycle
(either from the patient or donor), i.e., not a fresh embryo created
during the current cycle. Frozen embryos can be created from either
fresh or frozen eggs and sperm.
Thrombosis--Formation of a blood clot in a vessel obstructing
the flow of blood through the circulatory system.
Tubal embryo transfer (TET)--Transfer of an early stage embryo
to the fallopian tube.
Tubal factor--A factor causing reduced fecundity that is
associated with structural, anatomic, or functional injury of one or
both fallopian tubes; the following are included: (1) Tubal
ligation, not reversed, (2) hydrosalpinx (in place), 3 History of
hydrosalpinx (treated--by either surgical removal or hysteroscopic
occlusion) and (4) any other tubal disease including but not limited
to pelvic or peritubal adhesive disease, prior tubal surgery, prior
ectopic pregnancy, or tubal occlusion (partial or complete without
hydrosalpinx).
Tubal ligation for contraception--Sterilization of the female by
constricting, severing, or crushing the fallopian tubes;
constriction may be with an encircling plastic ring or other
ligature.
Ultrasound--A technique for visualizing the follicles in the
ovaries and the gestational sac or fetus in the uterus, allowing the
estimation of size.
Unexplained infertility--Infertility in which no etiology (male
infertility, endometriosis, tubal factor, ovulatory disorders/PCO,
diminished ovarian reserve, uterine factor, or other factors (such
as immunologic, chromosomal, cancer chemotherapy or other systemic
disease) has been identified.
Unstimulated cycle--An ART cycle in which the woman does not
receive medication to stimulate follicular development such as
clomiphene or follicle stimulating hormone. Instead, natural
follicular development occurs.
Uterine factor--A factor causing reduced fecundity that is
associated with structural, anatomic, or functional injury to the
uterus whether repaired or not; includes septum, myoma,
Diethylstilbestrol (DES) exposure, intrauterine adhesions,
congenital anomalies.
Zygote--A normal (2 pronuclei) fertilized egg before cell
division begins.
Zygote intra fallopian transfer (ZIFT)--Eggs are collected and
fertilized, and the resulting zygote is then transferred to the
fallopian tube.
2 Pronuclei (2PN)--The earliest stage of embryonic development
that occurs just after fertilization but before the nucleus from the
sperm and the egg have fused (thus, 2 pronuclei are present). The
appearance of two pronuclei indicates normal fertilization and is
usually detected 16-20 hours after fertilization or insemination.
IV. Published Reports and Data Usage
A. Annual ART Reports
ART data are used to produce the annual Assisted Reproductive
Technology Fertility Clinic Success Rates Report, a key publication
available to Congress, individual clinics, consumers, the states,
and the general public. This report has 3 major sections:
(a) Commonly asked questions--provides background information
and an explanation of the data reporting process.
(b) Fertility clinic table--displays tabulated results of
success rates for all reported ART procedures at individual U.S.
fertility clinics.
(c) Appendices--contains summary of data validation; a glossary
of technical and medical terms used in the report; the names,
addresses, and telephone numbers of all reporting and non-reporting
clinics; and a list
[[Page 51819]]
of national consumer organizations offering support to people
experiencing infertility.
In addition, HHS/CDC publishes an annual Assisted Reproductive
Technology National Summary Report using pooled data presented as
graphs and charts to provide an in-depth picture of the type,
number, and outcomes of ART cycles performed in the United States.
HHS/CDC also uses the pooled data to publish an annual ART
Surveillance Summary in HHS/CDC's Morbidity and Mortality Weekly
Report (MMWR) with state-specific information on ART procedures and
their outcomes. These reports are primarily used by states for
state-based surveillance and to inform maternal and child health
programs.
B. Data Usage and Data Access
HHS/CDC retains a copy of each reporting ART program's annual
data files. In addition to the annual ART reports, the NASS database
is used to evaluate emerging ART research questions and to monitor
safety and efficacy issues related to ART treatment for improving
maternal and child health outcomes. ART data files are protected
under an Assurance of Confidentiality pursuant to Section 308(d) of
the Public Health Service Act (42 U.S.C. 242[m]). This assurance
allows HHS/CDC programs to assure that certain identifiable data
collected on individuals and institutions involved in research or
non-research projects remain confidential. Starting in 2013,
researchers may analyze ART surveillance data using the National
Center for Health Statistics' (NCHS) Research Data Center (RDC)
under authorization of Sections 304 and 306 of the Public Health
Service Act, 42 U.S.C.242(k) (See https://www.cdc.gov/art/AccessData.html). Researchers requesting access to the NASS data
files are subject to all RDC procedures and protocols.
Dated: August 19, 2015.
Pamela J. Cox,
Director, Division of the Executive Secretariat, Office of the Chief of
Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-21108 Filed 8-25-15; 8:45 am]
BILLING CODE 4163-18-P