[Federal Register Volume 65, Number 171 (Friday, September 1, 2000)]
[Notices]
[Pages 53310-53316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22425]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Reporting of Pregnancy Success Rates From Assisted Reproductive 
Technology Programs

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (DHHS).

ACTION: Final Notice.

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SUMMARY: This notice sets forth the requirements for Reporting of 
Pregnancy Success Rates from Assisted Reproductive Technology Programs 
as required by the Fertility Clinic Success Rate and Certification Act 
of 1992 (FCSRCA). This notice describes who shall report to CDC, 
describes the reporting system, and describes the process for reporting 
by each assisted reproductive technology clinic. This notice 
incorporates comments received by CDC on the draft notice that was 
published in the Federal Register on September 3, 1999 (64 FR. 48402). 
This Announcement supersedes the previous notice that was published in 
the Federal Register, August 26, 1997 (62 FR. 45259).

FOR FURTHER INFORMATION CONTACT: Assisted Reproductive Technology 
Epidemiology Unit at (770) 488-5250.

SUPPLEMENTARY INFORMATION: Section 2(a) of Pub. L. 102-493 (42 U.S.C. 
263a-1(a)) requires that each assisted reproductive technology (ART) 
program shall annually report to the Secretary 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 this act.
    Pub. L. 102-493, Sec. 8 (42 U.S.C. 263a-7) 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 Section 2(b) (42 U.S.C. 263a-1(b)) 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.''
    Section 6 (42 U.S.C. 263a-5) states that the Secretary, through the 
CDC, shall annually ``publish and distribute to the States and the 
public, pregnancy success rates reported to the Secretary under section 
2(a)(1) and, in the case of an assisted reproductive technology program 
which failed to report one or more success rates as required under each 
section, the name of each such program and each pregnancy success rate 
which the program failed to report.''
    In developing the definition of pregnancy success rates, CDC has 
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 of professional individuals who work with infertility 
issues), and RESOLVE, the National Infertility Association (a national, 
nonprofit consumer organization), as well as a variety of individuals 
with expertise and interest in this field.
    The first Federal Register notice that outlined reporting 
requirements for ART programs was published August 26, 1997 (62 FR 
45259) and solicited public comment. Because SART in conjunction with 
CDC made a number of revisions to the reporting process shortly after 
the publication of the first Federal Register notice, a second Federal 
Register notice was published on September 3, 1999 (64 FR 48402) that 
incorporated changes made to the reporting process. CDC also solicited 
public comment on this second draft document for the Reporting of 
Pregnancy Success Rates from Assisted Reproductive Technology Programs. 
The current Announcement incorporates comments received by CDC on the 
September 3, 1999, draft notice and supersedes both the August 26, 
1997, and the September 3, 1999, notices.

Reponse to Comments

    In response to our request for comments to the September 3, 1999, 
draft document outlining reporting requirements, we received two 
letters, one from a laboratory professional organization, and one from 
an individual serving as the laboratory director of an ART clinic. 
These letters contained 15 separate comments. Responses to these 
comments are as follows:
    1. There was concern that no consultation or communication had been 
conducted with the American Association of Bioanalysts (AAB) or its 
College of Reproductive Biology regarding the reporting requirements.
    Response: The AAB was consulted early during the process in which 
CDC explored mechanisms to implement FCSRCA. Specifically, a 
representative of AAB attended a 1996 meeting convened by CDC to 
discuss issues related to the collection and reporting of ART clinic 
success rate statistics. Other professional organizations were 
represented as well. Although AAB did not participate in the most 
recent round of discussions on the clinic reporting requirements, a 
laboratory professional has been included in all discussions about 
reporting requirements.
    2. There was an objection to the collection of data related to 
laboratory accreditation by the College of American Pathologists/
American Society of Reproductive Medicine (CAP/ASRM) program.
    Response: The 1992 Pub. L. 102-493 (42 U.S.C. 263a-1(a)), FCSRCA, 
requires CDC to report information on whether laboratories used by ART 
programs are certified under the CDC model state certification program. 
The model certification program was published in the Federal Register, 
July 21, 1999 (64 FR 39374). The model contained a set of quality 
standards for the performance of embryo laboratory procedures, 
maintenance of records, qualifications for laboratory personnel, and 
criteria for the inspection and certification of embryo laboratories. 
At this point, no state has adopted the model certification program, 
and thus no clinic is eligible for certification under the CDC model 
program. As a public service, CDC has agreed to include data on three 
non-federal laboratory accreditation programs in the annual ART Success 
Rates Reports. These are through the College of American Pathologists/
American Society for Reproductive Medicine (CAP/ASRM), Joint Commission 
on Accreditation of Healthcare Organizations (JACHO) and the New York 
State Tissue Bank

[[Page 53311]]

certification for ART laboratories (NYSTB). CDC consulted with ASRM and 
SART in gathering information on laboratory accreditation agencies that 
currently have systems for certifying embryo laboratories. CDC does not 
endorse these accreditation agencies, but rather is providing available 
accrediting information in response to public requests. This will be 
clearly stated in all Success Rates Reports that contain laboratory 
accrediting information.
    3. There was concern that there would not be sufficient external 
validation of a laboratory's accreditation status.
    Response: For an ART clinic's laboratory to be listed in the 
Success Rate Report as accredited by one of the three accrediting 
agencies (CAP/ASRM, JACHO, NYSTB) written documentation of such 
accreditation must be provided to SART concurrent with data collection.
    4. Because of CDC's exclusive use of the SART database and CDC's 
reliance on SART for external validation of reporting activities, CDC 
appears to be ceding its regulatory authority to a private entity 
(SART). DHHS should establish very clear guidelines for selecting, 
reviewing, and evaluating any private entity that is given 
responsibility for evaluating these reporting activities.
    Response: While the assisted reproductive technology programs are 
reporting their pregnancy success rate data to CDC through SART, CDC 
maintains ultimate control and authority over what information is 
contained in the annual pregnancy success rates report.
    CDC's authority to publish and disseminate the annual report is not 
being ceded to SART, but rather SART is serving as a valuable resource 
from which CDC can obtain the necessary information to fulfill its 
statutory obligation.
    SART has maintained a national database of ART cycle-specific data 
reported by each of its member clinics since 1986. Prior to the 
decision to partner with SART, CDC reviewed the SART reporting database 
and system and found that it provided the necessary information to 
publish an annual report as required by FCSRCA. Rather than duplicate 
SART's reporting system and thereby burden ART clinics, CDC has 
contracted with SART to annually obtain a copy of their clinic specific 
database. Notice of this contract was published in Commerce Business 
Daily Journal June 2, 1997. The decision to purchase the SART database 
was also published in the first Federal Register Notice detailing ART 
clinic reporting requirements (62 FR 45259). As a result of the 
contract with CDC, clinics that are not members of SART are now also 
eligible to submit data to the SART reporting system in order to meet 
their requirement to report data under FCSRCA. SART has agreed to 
accept data from non-SART member clinics without imposing membership 
requirements.
    As part of its contract with CDC, SART is required to perform 
validation site visits for a portion of the clinics submitting data to 
its reporting system. CDC oversees and participates in all stages of 
the data validation process. CDC is present at meetings of the 
validation committee and maintains final approval of all validation 
materials. Additionally, a CDC representative attends approximately 
one-third of all validation site visits as an observer.
    5. A separate comment on validation activities expressed further 
concern that CDC contracts with SART to perform external validation 
visits. There was a recommendation that a separate body be used because 
of SART's role in the reporting process.
    Response: The SART validation committee is required to include at 
least one non-SART member at all times. Additionally, CDC attends all 
validation committee meetings and a proportion of validation site 
visits. Finally, CDC must approve SART's validation plan and retains 
ultimate authority over the validation process.
    6. There was concern about the external validation procedure, 
namely that ART cycles for which social security number is not provided 
to the database will not be able to be validated.
    Response: Even though specific identifiers are not submitted to CDC 
for any ART cycle, every clinic is required to maintain a copy of all 
information submitted to the reporting database and must be able to 
link each patient, cycle, and oocyte retrieved from the reporting 
database to the appropriate medical and laboratory records for external 
validation activities on site.
    7. There was concern that informed consent was not mentioned in the 
Federal Register notice.
    Response: Patients are not contacted directly during the data 
collection/validation process. The validation team does not collect 
personal identifying information when conducting validation visits.
    8. There was an objection to reporting data related to SART 
membership.
    Response: Consumers and consumer groups have indicated that such 
information is useful. CDC provides this information as a public 
service.
    9. There was concern that an unreasonably short time frame was 
given for reporting, i.e., that SART need only provide the clinics with 
the required software 90 days prior to the deadline for reporting.
    Response: CDC agrees that clinics should have as much lead time as 
possible. In the usual protocol, SART issues the data collection 
software and statistical tabulation program at the beginning of the 
reporting year, which is well in advance of the 90-day deadline. This 
deadline exists in the event that minor changes to the tabulation 
program are made. The revised software can then be reissued to clinics 
90 days prior to the reporting deadline.
    10. There was an objection to the requirement that clinics pay a 
fee to a private entity for data collection. There was a request that 
clarification on costs and cost justifications be provided.
    Response: Fees are for the purposes of covering all cost associated 
with reporting information, including data collection, processing, 
analysis, publication, and administration. Additional fees may be 
charged if SART needs to provide technical assistance to clinics 
submitting a dataset with errors.
    11. There was a recommendation that pregnancy outcomes should be 
reported separately for cycles using a combination of ART techniques, 
such as in vitro fertilization and gamete intrafollopian transfer.
    Response: In the national section of each ART Report, success rates 
for in vitro fertilization (IVF), gamete intrafallopian transfer 
(GIFT), and zygote intrafallopian transfer (ZIFT) are presented 
separately. Because the success rates are similar for each of the 
procedures and because there is often a small number of GIFT and ZIFT 
procedures at the individual clinic level, success rates for each type 
of ART procedure are not presented separately for each clinic.
    12. There was concern about the definitions for preterm birth and 
stillbirth after ART.
    Response: The decision to use date of transfer in defining 
gestational age was made by SART and CDC because date of transfer 
allows for a consistent definition for both fresh and frozen cycles. 
This issue will be discussed further and may be reconsidered at the 
next CDC-SART registry meeting.
    13. There was an objection to reporting data related to whether ART 
services were available for single women.
    Response: Consumers and consumer groups have indicated that such

[[Page 53312]]

information is useful. CDC provides this information as a public 
service.
    14. There was an objection to the collection of ethnicity data.
    Response: CDC collects data on demographics such as ethnicity in 
many surveillance systems. In this case, such information is intended 
to help describe groups that are using ART in the United States.
    15. There was concern that too much information is being included 
in the reporting system.
    Response: We have developed the ART report with consideration for 
the spirit of the 1992 FCSRCA (Pub. L. 102-493), consumer interests, 
and ART provider and clinic interests. Indeed, many providers and 
consumers have asked us to collect and report even more information 
than is currently included in the reporting system. Many providers have 
expressed concern that without consideration for many patient treatment 
factors the report will misrepresent clinic success rates. Of course, 
consumers are also very interested in a thorough and complete analysis, 
which will help in their goal of making an informed decision about ART.

    Dated: August 28, 2000.
Candice Norwicki,
Acting Director, Executive Secretariat, Centers for Disease Control and 
Prevention (CDC).

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 CDC.
    II. Description of Reporting Process * * * describes the 
reporting system and process for reporting by each ART clinic.
    III. Data To Be Reported * * * describes the data items and 
definitions to be included in the reporting database.
    IV. Content of the Published Report * * * describes terms, and 
how pregnancy success rates will be defined and reported, and 
outlines the topics that will be included in the annual published 
reports, using the data collected in the reporting database.

I. Who Reports

    The Fertility Clinic Success Rate and Certification Act of 1992 
(FCSRCA) requires that each ART program shall annually report to the 
Secretary of the Department of Health and Human Services through the 
CDC.
    The Society for Assisted Reproductive Technology (SART), an 
affiliate of the American Society for Reproductive Medicine (ASRM), 
maintains a national database of cycle-specific data reported by 
each of its members. CDC has reviewed the SART reporting database 
and system and finds that it provides the necessary information to 
publish an annual report as required by the FCSRCA. Rather than 
duplicate SART's reporting system, and thereby burden ART clinics 
and patients, CDC has contracted with SART to annually obtain a copy 
of their clinic specific database.
    An ART program or clinic is defined as a legal entity practicing 
under State law, recognizable to the consumer, that provides ART to 
couples who have experienced infertility or are undergoing ART for 
other reasons. This can be an individual physician or a group of 
physicians who practice together and share resources and liability. 
This definition precludes individual physicians who practice 
independently from pooling their results for purposes of data 
reporting.
    ART clinics that are participating in the ASRM/SART reporting 
system as described in this notice will be considered to be in 
compliance with federal reporting requirements of FCSRCA. Both SART 
and non-SART clinics shall contact SART for reporting information, 
instructions, and fees charged (fees are for the purposes of 
covering all costs associated with this activity, including data 
collection, processing, analysis, publication, and administration; 
additional fees may be charged if SART needs to provide technical 
assistance to clinics submitting a dataset with errors.) It is the 
responsibility of the practice director of each clinic performing 
ART to provide notification to SART of the clinic's existence and 
any changes in address, location, or change in key staff including 
the practice, medical, and lab director. Contact SART, telephone: 
(205) 978-5000, ext. 109.
    The anticipated deadline for reporting is January 15 of the year 
2 years subsequent to the reporting year in question. (For example, 
the anticipated deadline to report data on cycles initiated in 1999 
is January 15, 2001.) The deadline will be published in Fertility 
and Sterility at least 90 days prior to the deadline. SART in 
conjunction with CDC may change the deadline if needed.
    An ART clinic will be considered to not be in compliance with 
the federal reporting requirements of FCSRCA if the clinic was in 
operation in the full year that is being reported, i.e., the clinic 
was in operation after January 1, and failed (a) to submit a dataset 
to SART in the required software by the reporting deadline or (b) 
the clinic table was not verified by signature of the medical 
director of the clinic by the same deadline.
    The onus is on the clinic to confirm that SART has received the 
dataset. It is recommended that the clinic submit their data to SART 
as early as it is available so that any errors or reporting 
difficulties can be reconciled and verified before the reporting 
deadline which will be inflexible. In this respect, it would be 
prudent to submit data to SART at least 30 days in advance of the 
reporting deadline because errors or other problems in reporting may 
take up to 30 days to resolve. If problems cannot be resolved by the 
inflexible deadline of January 15, the clinic will be considered a 
non-reporter.
    SART in conjunction with CDC will determine error rates for data 
submitted by clinics, and if data quality is deemed unsatisfactory, 
this finding may be published. Additionally, the program may be 
required to submit data 30 days prior to the deadline for the next 
reporting year. This requirement will allow for sufficient time to 
correct errors prior to the deadline for publication of the annual 
report. As noted earlier, additional fees may be charged if SART 
needs to provide technical assistance to clinics submitting a 
dataset with errors.

II. Description of Reporting Process

A. Reporting Activities

    SART in conjunction with CDC will determine the required 
software for data submission. As noted above, to be in compliance 
with the law, a clinic must submit a dataset to SART in the required 
software by the reporting deadline, and verify, by signature of the 
medical director of the clinic, the clinic table by the same 
deadline.
    Each year, SART will issue a unique clinic code, required 
computer software for their database reporting system, and all 
necessary reporting instructions at least 90 days in advance of the 
reporting deadline.
    Currently, each patient receiving ART in a clinic is registered 
in the system with a unique, clinic-assigned code and should be 
entered into the reporting database when her cycle is initiated. 
Each cycle of each patient also receives a unique cycle code for 
that patient. In the reporting system, the patient is identified by 
the clinic code, the patient code, and the cycle code assigned by 
the clinic. The patient's name or other specific personal 
identifiers are not included in the reporting database. However, 
each clinic must maintain personal identifiers in the clinic 
database on site in order to be able to link every cycle reported to 
CDC to a specific patient (see below).
    The following patients must be included in the reporting 
database: (1) All women undergoing ART, (2) all women undergoing 
ovarian stimulation or monitoring with the intention of undergoing 
ART; this includes women whose cycles are canceled for any reason, 
(3) all women providing donor oocytes, and (4) all women undergoing 
monitoring and/or an embryo thawing with the intention of 
transferring cryopreserved embryos.
    It is anticipated that the reporting system may evolve such that 
data may be collected prospectively, i.e., data submission will be 
required as cycles are initiated. (Currently data submission for all 
cycles is required at one time only.) Clinics will be provided at 
least 90 days advance notice of this or other changes in reporting 
requirements.
    The CDC retains a copy of each of SART's annual data files. 
These will be maintained by CDC to be used for epidemiologic 
analysis and for the purpose of publishing an annual report as 
required by the law that includes national summary and clinic 
specific information.

B. External Validation of Clinic Data

    Every clinic will maintain a copy of all information included in 
the reporting database and must be able to link each patient, cycle, 
and oocyte retrieved from the reporting database to the appropriate 
medical and laboratory records for external validation activities.

[[Page 53313]]

    On a periodic basis, all ART clinical programs reporting their 
data (both SART and non-SART clinics) will be subject to external 
validation of their reporting activities, which will include review 
by appropriate professionals from outside the clinic staff. This 
review may include but not be limited to examination of medical and 
laboratory records and comparison of data in the reporting database 
with data in the medical record. CDC has contracted with SART to 
perform the validation site visits.

C. Updating of Reporting Requirements

    The field of ART is a rapidly developing medical science. These 
reporting requirements will be periodically reviewed and updated as 
new knowledge concerning ART methods and techniques becomes 
available. Such review will include consultation with professional 
and consumer groups and individuals. Clinics will be notified in 
writing at least 90 days in advance of the reporting deadline of all 
changes to the reporting requirements.

III. Data To Be Reported

    The current reporting system includes the following:

A. Clinic Information

Clinic name & address
Unique clinic ID number
Name(s) of embryo laboratory(s) used by clinic
Whether the laboratory is certified by a SART-accepted accrediting 
agency
Whether the clinic is a member of SART
Whether ART services are available for single women
Whether ART services include gestational carriers
Whether the clinic has a donor egg program, and if yes, if eggs from 
an individual donor are shared by multiple recipients
Whether the clinic has a donor embryo program
Whether the clinic has an embryo cryopreservation program
Total number of ART cycles performed during the reporting year

B. Patient Information

1. Patient Demographic Information:
    Ethnicity
    Date of Birth
    US Resident
    Zip Code
    City of Residence
    State of Residence
    Country of Residence (if not United States)
2. Patient History:
    Gravidity
    Prior Full-Term Births
    Prior Preterm Births
    Prior Spontaneous Abortions
    Surgical Sterilization--Patient or Partner
    Months of Infertility Since Last Live birth (if couple is not 
surgically sterile)
    Prior non-ART Gonadotropin Cycles
    Prior Thawed ART Cycles
    Prior Fresh ART Cycles
    Patient Maximum Follicle Stimulating Hormone (FSH) Level and Lab 
Upper Normal Limit for that FSH level
    Patient Maximum Estradiol Level and Lab Upper Normal Limit for 
that Estradiol Level
3. ART Cycle Information: 
    Reason(s) for ART
    (Male Infertility, Endometriosis, Tubal Factor, Ovulatory 
Disorder/Polycystic Ovaries, Diminished Ovarian Reserve, Uterine 
Factor, Other, Unexplained Infertility)
    Cycle Start Date
    Suppression with Gonadotropin Releasing Hormone Analog (GnRHa)
    Ovarian Stimulation Medications Given to Patient (Clomiphene, 
FSH, Flare GnRHa) and Dosages
    Medications Given to Oocyte Donor and Dosages
    Intended ART Cycle Treatment Specifics:
    Oocyte Source
    (patient [autologous], donor oocyte, donor embryo)
    Oocyte/Embryo State
    (fresh, thawed)
    Intended Transfer Method(s)
    [In Vitro Fertilization (transcervical transfer); Gamete 
Intrafallopian Transfer; Zygote Intrafallopian Transfer/Tubal Embryo 
Transfer]
    Use of Gestational Carrier
    Cycle Initiated for Embryo Banking Only
    Cycle Meeting SART Criteria for Approved Research
    Did the Cycle Occur as Intended?
    Was the Cycle Canceled?
    Date of Cancellation
    Reason for Cancellation
    (Low Ovarian Response, High Ovarian Response, Failure to Survive 
Thaw, Inadequate Endometrial Response, Concurrent Illness, Patient 
Withdrawal from Treatment, Unable to Obtain Sperm Specimen)
    Complications Related to ART Treatment
    (Infection, Hemorrhage, Moderate Ovarian Hyperstimulation 
Syndrome, Severe Ovarian Hyperstimulation Syndrome, Medication Side 
Effect, Anaesthetic Complication, Psychological Stress, Death, Other 
Complication)
    Hospitalization for ART Complication
    Date of Oocyte Retrieval (from patient and/or from donor)
    Number of Oocytes Retrieved (both from patient and/or from 
donor)
    Were Oocytes Derived from the Donor Used by More Than One 
Recipient?
    Number of Embryos Thawed for Transfer in a Frozen Cycle
    Semen Source
    (Partner, Donor, Mixed)
    Semen Collection Method
    (Ejaculation, Epididymal Aspiration, Testicular Biopsy, 
Electroejaculation, Retrograde Ejaculation)
    Use of Intracytoplasmic Sperm Injection
    Use of Assisted Hatching
    Was Oocyte or Embryo Transfer Attempted?
    Transfer Date
    Number of Fresh Embryos Transferred to Uterus
    Number of Fresh Embryos Transferred to Fallopian Tubes
    Number of Oocytes Transferred to Fallopian Tubes
    Number of Fresh Embryos Cryopreserved
    Number of Thawed Embryos Transferred to Uterus
    Number of Thawed Embryos Transferred to Fallopian Tubes
    Number of Thawed Embryos Re-Frozen
4. Outcome Information:
    Outcome of Treatment
    (Not Pregnant, Biochemical Pregnancy, Ectopic Pregnancy, 
Clinical Intrauterine Gestation, Heterotopic Pregnancy, Unknown)
    Was an Ultrasound Performed?
    Ultrasound Date
    Maximum Number of Fetal Hearts Observed on Ultrasound
    Was a Medically Induced Fetal Reduction Performed?
    Induced Reduction Date
    Outcome of Pregnancy
    (Live birth, Stillbirth, Spontaneous Abortion, Induced Abortion, 
Maternal Death Prior to Birth, Unknown)
    Date of Pregnancy Outcome
    Source of Information for Outcome of Pregnancy
    (Verbal Confirmation Patient, Written Confirmation Patient, 
Verbal Confirmation Physician or Hospital, Written Confirmation 
Physician or Hospital)
    Number of Infants Born
    Birth weight for Each Live-born and Stillborn Infant
    Birth Defects Diagnosed for Each Live-born and Stillborn Infant
    (Genetic Defect/Chromosomal Abnormality, Cleft Lip or Palate, 
Neural Tube Defect, Cardiac Defect, Limb Defect, Other Defect)
    Neonatal Death of Live-born Infants

C. Definitions

    The following definitions provide clarification for data 
included in the current reporting system:
    ART--Assisted reproductive technology, defined as all treatments 
or procedures that include the handling of human oocytes and sperm 
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, 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, a woman began 
medication for endometrial preparation with the intent of undergoing 
ART and/or embryos were thawed with the intent of transfer.
    ART program or clinic--A legal entity practicing under state 
law, recognizable to the consumer, that provides assisted 
reproductive technology to couples who have

[[Page 53314]]

experienced infertility or are undergoing ART for other reasons. 
This can be an individual physician or a group of physicians who 
practice together, and share resources and liability. This 
definition precludes individual physicians who practice 
independently from pooling their results for purposes of data 
reporting.
    ASRM--American Society for Reproductive Medicine.
    Autologous cycle--Intent to transfer embryos derived from 
patient oocytes fertilized with either partner or donor sperm OR in 
cases of GIFT, patient oocytes transferred with either partner or 
donor sperm.
    Birth defect--Anomalies diagnosed within the first two weeks of 
life that result in death or cause 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.
    Canceled cycle--An ART cycle in which ovarian stimulation or 
monitoring has been carried out with the intent of undergoing ART 
but which did not proceed to oocyte retrieval, or in the case of 
thawed embryo cycles, to the transfer of embryos. Reasons for 
cancellation include low ovarian response, high ovarian response, 
failure of embryo to survive thaw; inadequate endometrial response, 
concurrent illness, patient withdrawal from treatment, and unable to 
obtain sperm specimen.
    Clinic ID number--An identification number assigned to each ART 
clinical program by the reporting database operator.
    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 the 
trade name of Clomid or SeroPhene.
    Complication--A medical complication for the woman related to 
ART procedures. Specific complications to be identified include 
infection, hemorrhage, moderate ovarian hyperstimulation syndrome, 
severe ovarian hyperstimulation syndrome, medication side effect, 
anaesthetic complication, psychological stress requiring 
intervention, and death.
    Cryopreservation--A technique used in ART to preserve sperm and 
embryos through freezing.
    Cycle start date (cycle initiation date)--The cycle start date 
is (1) the first day that medication to stimulate follicular 
development is given to a patient in a stimulated fresh, non-donor 
cycle, or (2) the first day of natural menses or withdrawal bleeding 
in an unstimulated cycle or (3) the first day the recipient (patient 
or gestational carrier) receives exogenous sex steroids to prepare 
the endometrium in a fresh donor cycle, or (4) the first day the 
recipient (patient or gestational carrier) receives exogenous sex 
steroids to prepare the endometrium in a thawed embryo cycle.
    Diminished ovarian reserve--A condition of reduced fecundity 
related to diminished ovarian function; includes high FSH or high 
estradiol measured in the early follicular phase or during a 
clomiphene challenge test, reduced ovarian volume related to 
congenital, medical, surgical or other causes, or advanced maternal 
age (>40 years).
    Donor embryo cycle--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--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.
    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 fertilized 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 transfer--Attempt to introduce embryos into a woman's 
uterus after in vitro fertilization 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 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.
    Estradiol (E2)--The predominant estrogen hormone produced by the 
ovary that has several activities important for reproduction. An 
elevated serum Estradiol level in the early follicular phase of a 
woman's menstrual cycle (day 2, 3, or 4) may indicate diminished 
ovarian reserve.
    Fecundity--The ability to conceive.
    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--Use of a GnRH analog to directly stimulate 
follicle development.
    Follicle--A fluid-filled sac located just beneath the surface of 
the ovary that contains an oocyte and cells that produce hormones.
    Fresh oocyte or embryo cycle--Intent to transfer oocytes or 
embryos derived from oocytes retrieved during the current cycle 
(either from the patient or donor), i.e., not thawed embryos 
retrieved during a previous cycle.
    FSH--Follicle stimulating hormone. A gonadotropin hormone 
produced and released from the pituitary that stimulates the ovary 
to ripen a follicle for ovulation. An elevated serum FSH level in 
the early follicular phase of a woman's menstrual cycle (day 2, 3, 
or 4) or during a clomiphene challenge test (day 10 of the cycle) 
may indicate diminished ovarian reserve. FSH, either alone or with 
luteinizing hormone (LH), is also included in gonadotropin drug 
preparations used to stimulate follicular development during an ART 
cycle.
    Full-term birth--A birth that reached 37 completed weeks 
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.
    GnRHa-Gonadotropin--releasing hormone analog (agonist or 
antagonist); medications used to suppress natural FSH and LH 
production to allow greater control when using follicle stimulation 
medications.
    Gestational carrier (sometimes referred to as a gestational 
surrogate)--A woman who gestates an embryo that did not develop from 
her egg with the expectation of returning the infant to its intended 
parents.
    Gestational sac--A fluid-filled structure surrounding an embryo 
that develops within the uterus early in pregnancy.
    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.
    Gravidity--Total number of prior pregnancies a woman has had. 
This includes ectopic pregnancies, and pregnancies that ended in 
therapeutic abortion, spontaneous abortion, stillbirth, or live 
birth.
    Hatching (Assisted)--A micromanipulation technique that involves 
making a small opening in the zona wall of the embryo in an effort 
to enhance implantation; various methods of assisted hatching have 
been utilized including chemical, laser, and mechanical methods.
    Heterotopic pregnancy--A clinical intrauterine gestation in 
combination with an ectopic pregnancy.

[[Page 53315]]

    Hydrosalpinx--Accumulation of watery fluid in a fallopian tube 
that usually results from damage to the tube.
    Hypothalamus--A gland at the base of the brain that controls 
many functions of the body, regulates the pituitary gland, and 
releases gonadotropin releasing hormone (GnRH).
    Induced abortion--Operative procedure to electively terminate 
the entire pregnancy (no gestational age limit).
    Induced fetal reduction--A procedure in which the number of 
fetal sacs is reduced by direct medical intervention. Termination of 
an ectopic gestation or a heterotopic pregnancy is not considered an 
induced reduction. Induced reduction is used in women with multiple 
gestations, usually three or more, to decrease the number of fetuses 
a woman carries, usually to two.
    Insemination--Injection of sperm into the uterus or cervix for 
the purpose of producing a pregnancy. Insemination cycles are not 
considered ART for the purposes of this notice.
    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.
    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. 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).
    Male infertility--Infertility due to abnormal semen parameters 
or abnormal sperm function.
    Neonatal death--Death of a live-born infant before completion of 
the 28th day of life.
    Oocyte--The female reproductive cell, also called an egg.
    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). The donor relinquishes all parental rights to any resulting 
offspring, while the recipient woman retains all parental rights of 
any resulting offspring.
    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 syndrome--A possible complication 
related to medically induced ovulation. Moderate ovarian 
hyperstimulation syndrome is characterized by abdominal distension 
and discomfort as well as nausea, vomiting and/or diarrhea; ovaries 
enlarged 5-12 cm; and ultrasound evidence of ascites. Severe ovarian 
hyperstimulation syndrome is characterized by features of moderate 
ovarian hyperstimulation PLUS: clinical evidence of ascites (fluid 
in the abdominal cavity) and/or hydrothorax (fluid in the chest) or 
breathing difficulties; change in blood volume, increased blood 
viscosity due to hemoconcentration, coagulation abnormalities, and 
diminished kidney perfusion and function.
    Ovulatory disorder/polycystic ovaries (PCO)--One or more 
disorders causing reduced fecundity that is associated with 
structural, anatomic, or functional impairment of one or both 
ovaries; includes multiple ovarian cysts affecting fertility, oligo-
ovulation (6 cycles per year), anovulation (of hypothalamic or non-
hypothalamic causes).
    Ovulation induction--See stimulated cycle.
    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.
    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).
    Preterm birth--Birth at least 20 but less than 37 completed 
weeks 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.
    SART--Society for Assisted Reproductive Technology.
    Semen--Fluid discharged at ejaculation in the male, consisting 
of spermatozoa in their nutrient plasma which includes secretions 
from the prostate, seminal vesicles, and various other glands.
    Sperm--The male reproductive cell that has completed the process 
of meiosis and morphological differentiation.
    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 without reversal. Surgical sterilization 
includes tubal ligation, vasectomy and hysterectomy.
    Thawed cycle-- Intent to transfer embryos that were 
cryopreserved during a previous cycle and will be thawed for 
transfer during the current cycle (pertains to both donor and non-
donor embryos).
    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), and (3) 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).
    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.

D. Updating Data To Be Reported

    Specific data items and definitions will be provided to clinics 
each year along with all other reporting requirements at least 90 
days in advance of the reporting deadline. Data items and 
definitions will be periodically reviewed and updated. Such review 
will include consultation with professional and consumer groups and 
individuals.

[[Page 53316]]

IV. Content of Published Reports

    The data reported will be used to provide a picture of the 
national rates of pregnancy and live birth achieved using ART as 
well as clinic-specific, live-birth rates. The annual report will 
have four components:
    (A) A national component, which will provide a comprehensive 
picture of success rates given a variety of factors including age, 
reason for ART, type of ART procedure, number of embryos transferred 
etc. This is possible because the large number of cycles at the 
national level allow accurate statistical reporting of success rates 
that is not possible with the smaller number of cycles carried out 
in individual clinics.
    (B) A clinic-specific component which will provide success rates 
for all ART cycles using fresh, non-donor embryos, success rates for 
ART cycles using thawed embryos, and success rates for ART cycles 
using donor oocytes or embryos.
    Success rates will be reported by specific age groups. In 
addition, the clinic-specific component will provide other 
information that may be useful to the consumer such as types of 
services the clinic offers (e.g., gestational surrogacy, single 
women), the number of cycles carried out, the percent distribution 
of types of ART, the types of infertility problems the clinic sees, 
the frequency of cancellations, the average number of embryos 
transferred per cycle and the percentage of multiple pregnancies and 
births (twins and triplets or greater).
    Pregnancy and live birth success rates will be defined and 
characterized as described below.
    For fresh, non-donor cycles, success rates will be defined as
    1. The rate of pregnancy after completion of ART according to 
the number of:
    a. All ovarian stimulation or monitoring procedures.
    2. The rate of live birth after completion of ART according to 
the number of:
    a. All ovarian stimulation or monitoring procedures.
    b. Oocyte retrieval procedures.
    c. Embryo (or zygote, or oocyte) transfer procedures.
    For cycles using thawed embryos and cycles using donor oocytes 
or embryos success rates will be defined as
    1.The rate of live birth after completion of ART according to 
the number of:
    a. Embryo (or zygote, or oocyte) transfer procedures.
    (C) An appendix containing a consumer-oriented explanation of 
all medical and statistical terms used in the report.
    (D) An appendix containing a list of all reporting clinics and a 
list of all clinics that did not report data (See above, Who Reports 
section, for a full description of clinics that will be considered 
to not be in compliance with the federal reporting requirements of 
FCSRCA; such clinics will be listed as non-reporters in the 
published report.) This appendix will contain the names, addresses, 
and telephone numbers for all reporting and non-reporting clinics. 
It will also contain information on the laboratories used by 
reporting clinics.
    The entire annual report will be available to the general 
public. As resources allow, additional information may also be 
published.

[FR Doc. 00-22425 Filed 8-31-00; 8:45 am]
BILLING CODE 4163-18-P