[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: 
[email protected].

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 
[email protected]. 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 http://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