[Federal Register Volume 62, Number 165 (Tuesday, August 26, 1997)]
[Notices]
[Pages 45259-45263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Draft Document: Reporting of Pregnancy Success Rates From 
Assisted Reproductive Technology Programs; Notice of Comment Period

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

ACTION: Notice; request for comment.

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SUMMARY: This notice is a request for comment and review of the draft 
document for the 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).

DATES: This notice is effective for the calendar year 1997 and beyond. 
In order to report outcomes of pregnancies during a calendar year, 
clinic specific data will be collected through October of the following 
calendar year (e.g., outcomes of pregnancies occurring during calendar 
year 1997 will be collected through October 1998). CDC will publish its 
first annual report under this notice in March 1999.
    To ensure consideration, written comments on this document must be 
received on or before September 25, 1997.

ADDRESSES: Comments shall be submitted to: George Walter, M.S.P.H., 
Women's Health and Fertility Branch, Division of Reproductive Health, 
National Center for Chronic Disease Prevention and Health Promotion, 
Centers for Disease Control and Prevention (CDC), Mailstop K-34, 4770 
Buford Hwy, NE., Atlanta, Georgia 30341-3724.

FOR FURTHER INFORMATION CONTACT:
George Walter, M.S.P.H., telephone (770) 488-5204, E-Mail Address: 
[email protected].

SUPPLEMENTARY INFORMATION: Section 2(a) of Pub. L. 102-493 (42 U.S.C. 
263a-1) requires that each 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, Section 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) 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 2c states: In developing the definitions under subsection 
(b), ``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 requires the Secretary, through the CDC, to 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.''
    CDC has prepared these proposed reporting requirements after 
discussion with representatives of the Society for ART (a national 
professional association of ART clinical programs), the American 
Society for Reproductive Medicine (a national society of professional 
individuals who work with infertility issues), the College of American 
Pathologists (a national professional association of pathologists 
having an accreditation program for reproductive laboratories), the 
American College of Obstetricians and Gynecologists (a national society 
of obstetricians and gynecologists), RESOLVE (a national consumer 
association of couples with infertility diagnoses), and the New England 
Patients' Rights Group (a regional consumer association concerned with 
patients' rights and informed consent issues), as well as a variety of 
individuals with expertise and interest in this field.
    This notice provides opportunity for public review and comment (see 
appendix).

    Dated: August 20, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, 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. Proposed Data to be Reported * * * includes the definition 
of terms used in the reporting database. These definitions are 
provided only for the purpose of clarity in reporting data and are 
not intended to define standards of medical care.
    IV. Definitions * * * describes terms, and how pregnancy success 
rates will be defined and reported, and outlines the topics and 
analyses 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 assisted reproductive technology program 
shall annually report to the Secretary of the Department of Health and 
Human Services through the CDC pregnancy success rates and the 
certification status of its embryology laboratory.
    The Society for Assisted Reproductive Technology (SART), an 
affiliate of the

[[Page 45260]]

American Society for Reproductive Medicine (ASRM), maintains a national 
database of cycle specific data reported by each of its members. As a 
condition of SART membership, each ART clinic must submit clinic 
specific data to SART and agree to on site date validation site visits 
by SART.
    CDC has reviewed the SART reporting database and system and found 
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 will contract 
with the SART to obtain a copy of their clinic specific database.
    ART clinics that participate in the ASRM/SART reporting system as 
described in this notice, will be considered to be in compliance with 
the reporting requirements of FCSRCA.
    Any ART program that is not a member of SART shall contact CDC 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.)
    Contact George Walter, M.S.P.H., telephone (770) 488-5204.

II. Description of Reporting Process

A. Reporting Activities

    SART issues a unique clinic code, computer software for their 
database reporting system, and all necessary reporting instructions.
    Each patient receiving ART in a clinic is registered in the system 
with a unique, clinic-assigned identifier 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 center code, the 
patient code, and the cycle code assigned by the clinic; the patient's 
name is not included in the reporting database. However, the individual 
clinics must be able to use these codes to link every cycle to a 
specific patient (see below). The following patients are 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 an embryo thawing with the intention of transferring 
cryopreserved embryos.
    Clinic patitents will be informed through consent forms that their 
cycle specific data will be provided to the CDC and that all personal 
identifiers submitted to CDC in the SART data set will be protected 
under the Privacy Act. If a patient indicates that they do not want 
their personal identifier reported, the personal identifier will not be 
included.
    The CDC will retain a copy of each of SART's annual data files. 
These will be used for epidemiologic analysis and for the purpose of 
publishing an annual report as required.

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 
occyte retrieved from the reporting database to the appropriate medical 
and laboratory records for external validation activities.
    On a periodic basis, ART clinical programs will be subject to 
external validation by SART 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, comparison of data in the reporting 
database with data in the medical record, and direct communication with 
patients included in the reporting database. Each patient included in 
the reporting database should be counseled that he or she may be 
contacted by professional reviewers as part of routine data validation 
and asked to confirm information provided in the database. Every 
patient should have an informed consent document in the medical record 
indicating that he or she has been counseled concerning this possible 
contact and has agreed or refused to participate in the data validation 
process.

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, such as the consultations obtained for this initial 
notice. All notices for revision of the reporting requirements will be 
published in the Federal Register with a comment period.

III. Proposed Data To Be Reported*

A. Clinic Information

     Name and address.
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    * These items are currently collected by SART and will be 
purchased by CDC.
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     Unique clinic ID number.
     Name(s) of embryo laboratory(s) used by clinic.
     Years ART program has been practicing under the above 
clinic name.
     Number of ART patients seen during the reporting year.
     Total number of ART cycles performed during the reporting 
year.

B. Patient information

1. Identification
     Patient ID number (e.g., medical record number).
     Social Security Number.
     Date of birth.
     Race and ethnicity.
2. Reproductive History
     Gravidity.
     Prior total ART cycles (performed at reporting clinic, 
plus all other clinics).
     Prior live births.
     ART cycles since last birth (if applicable).
3. Cycle Specific Information
a. Identification
     Unique cycle specific number.
     Date ART initiated.
     Date ART canceled (if applicable).
     Date of Retrieval (if applicable).
     Date of transfer (if applicable).
b. Art Procedure Information
     Pre-treatment diagnosis (primary and secondary).
     Type of ART performed.
     Use of surrogacy/gestational carrier.
     Stimulation medication with dosage (if applicable).
     If canceled, reason for cancellation (illness, small 
number or no follicles), and if other forms of treatment such as 
artificial insemination (therapeutic insemination), timed intercourse, 
etc., are carried out.
     Number of oocytes retrieved (if applicable).
     Sperm source (e.g., partner, donor, or mixed) and 
motility.
     Use of micromanipulation for male factor (e.g., ICSI, PZD, 
or SUZI).
     Use of assisted hatching.
     Number of embryos frozen.
     Number of fresh (or thawed) embryos/oocytes transferred.
c. Outcome Information
     Results of pregnancy test and ultrasound (when 
applicable).
     Type of pregnancy (e.g., biochemical, clinical or 
ectopic).
     Date and number (in sacs) of pregnancy reduction.
     Outcome of clinical pregnancy (spontaneous or induced 
abortion, live birth, still birth).

[[Page 45261]]

     Birth outcome (birth weight, birth defects, neonatal 
death).
     Descriptions of complications (hyper stimulation syndrome, 
anesthesia complications, hospitalization).

IV. Definitions

(Numbers in parentheses refer to references at end of this document.)
    ART--Assisted reproductive technology, defined as all treatments or 
procedures which 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, gamete intrafallopian 
transfer, zygote intrafallopian transfer, embryo cryopreservation, 
oocyte or embryo donation, and gestational surrogacy(2).
    ART Cycle--ART cycles can be stimulated (use of ovulation 
induction) or unstimulated (natural cycle (1). An ART cycle is 
considered any cycle in which: (1) ART has been used, (2) in which the 
woman has undergone ovarian stimulation or monitoring with the intent 
of undergoing ART, or (3) in the case of cryopreserved embryos, in 
which embryos have been 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 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. If a program or clinic has undergone significant staffing 
changes such as changes in medical director, lab director, or 
ownership, but maintains the same or similar program name that is 
recognizable to the consumer, the practice is considered a continuation 
of an existing program. This definition precludes individual physicians 
who practice independently from pooling their results for purposes of 
data reporting.
    ASRM--American Society for Reproductive Medicine.
    Birth defect--Anomalies identified within the first two weeks of 
life that result in death or cause a serious disability requiring 
surgical and/or medical therapy (4). Specific anomalies to be 
identified include cardiac defect, cleft lip, cleft palate, genetic 
defect, and limb defect.
    Biochemical pregnancy--A positive pregnancy test without the 
documented presence of a gestational sac.
    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 
cryopreserved embryo cycles, to the transfer of embryos.
    Center code--An identification number assigned to each ART clinical 
program by the reporting database operator.
    Clinical pregnancy--An ultrasound-confirmed gestational sac within 
the uterus or the documented presence of intrauterine products of 
conception. 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 spontaneous abortions, induced abortions, and 
deliveries (3).
    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, such as reactions to medications, anesthetic reaction, 
postsurgical bleeding, or infection.
    Cryopreservation--A technique to preserve tissue, both ovarian and 
testicular, through freezing.
    Cycle code--The ART cycle number for the particular patient. This 
code should be unique for each cycle in the same patient and is a 
separate number from the patient code. The patient code and cycle code 
together uniquely identify each cycle of each patient reported from the 
same clinic.
    Cycle start date (cycle initiation date)--The cycle start date is 
the day that: (1) a patient in a stimulated cycle begins ovarian 
stimulation; (2) a patient in an unstimulated cycle begins cycle 
monitoring with the expectation of undergoing ART (including 
cryopreserved embryo transfer); or (3) a patient in a donor recipient 
or cryopreserved embryo cycle begins endometrial stimulation by 
exogenous sex steroids (includes gestational surrogacy). See also 
stimulated and unstimulated cycles.
    Donor embryo--An embryo derived from the egg of a donor for 
transfer to a recipient. (4)
    Donor recipient cycle--A cycle in which the patient receives a 
donor embryo.
    Donor oocyte cycle--A cycle in which the patient donates some or 
all of her oocytes to a recipient.
    Down regulation--Use of a GnRH agonist to effect ovarian 
suppression prior to the initiation of ovarian stimulation.
    Ectopic pregnancy--A pregnancy in which the fertilized egg implants 
anywhere but in the uterine cavity (usually in the fallopian tube, the 
ovary, or the abdominal cavity) (3).
    Embryo--The normally (2 pronuclei) fertilized egg that has 
undergone one or more divisions (8).
    Embryo transfer--Introduction of embryos into a woman's uterus 
after in vitro fertilization (3).
    Endometriosis--The presence of tissue resembling endometrium in 
abnormal locations (locations outside the uterus) such as the ovaries, 
fallopian tubes, and abdominal cavity (4).
    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).
    Flare protocol--Use of a GnRH agonist starting with or after onset 
of menses of the cycle being entered to augment stimulation.
    Fress zygotes or embryos--Zygotes or embryos which have not been 
cryopreserved. Such zygotes or embryos may have been conceived using 
fresh or frozen sperm.
    FSH--Follicle stimulating hormone. A hormone produced and released 
from the pituitary that stimulates the ovary to ripen a follicle for 
ovulation.
    Gamete intrafallopian transfer (GIFT)--An ART procedure that 
involves removing eggs from the woman's ovary, combining them with 
sperm, and immediately injecting the eggs and sperm into the fallopian 
tube. Fertilization takes place inside the fallopian tube. (4)
    GnRHa--Gonadotropin-releasing hormone agonist (Lupron, 
Synarel and ``new'' products (high purified or 
recombinant)).
    Gestational carrier--A woman who gestates an embryo which did not 
develop from her egg with the expectation of returning the infant to 
its genetic parents.
    Gestational sac--A fluid-filled structure that develops within the 
uterus early in pregnancy (1).
    Hatching (Assisted)--A micromanipulation technique which involves 
making a small opening in the zona wall of the embryo to enhance 
implantation (8).
    Human chorionic gonadotrophin (hCG)--A hormone secreted by the 
products of conception derived from the urine of pregnant women. HCG is 
used to ripen the egg and trigger ovulation (8).
    Human menopausal gonadotrophin (hMG)--A hormone extracted from the 
urine of post-menopausal women. It is rich in the hormones FSH 
(follicle stimulating hormone) and LH (luteinizing hormone) and is used 
to stimulate follicular development and ovulation (8).

[[Page 45262]]

    Intrauterine Insemination (IUI)--The transfer of washed semen into 
a woman's uterus.
    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 eggs from a women's ovaries, combining them with 
sperm in the laboratory and, if fertilized, replacing the resulting 
embryo into the women's uterus. (4)
    Live birth--Any infant delivered with signs of life (delivered with 
assigned 1 or 5 minute Apgar scores of 1 or greater), at greater than 
or equal to 20 gestational weeks.
    Male factor--A deficiency in quantity and/or quality of sperm 
preventing successful fertilization. SART defines male factor as a 
sperm count of less than 20 million/milliliter and/or a motility of 40 
percent or less. Frozen semen from the male partner is classified by 
its original fresh characteristics, not its post-thaw values. If donor 
sperm are used alone or in combination with male partner's sperm, the 
cycle is not classified as male factor (3).
    Multiple pregnancy--A pregnancy with more than one fetus.
    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 donation--Removal of an egg from one women for eventual 
transfer into the fallopian tube (GIFT) or for a ZIFT or IVF embryo 
transfer to another woman. The donor relinquishes all parental rights 
to any resulting offspring, while the recipient women retains all 
parental rights of any resulting offspring.
    Oocyte donor--A woman who undergoes a donor oocyte cycle (see donor 
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 (3).
    Oocyte transfer--In GIFT (see definition), transfer of retrieved 
eggs into a woman's fallopian tubes via laparoscopy. Includes attempted 
transfer, whether or not the transfer was successful (3).
    Ovarian monitoring--Monitoring the development of ovarian follicles 
by ultrasound and/or blood or urine tests.
    Ovarian stimulation--A series of drugs used to stimulate the ovary 
to develop follicles and eggs (8).
    Ovulatory dysfunction--A factor causing reduced fecundity that is 
associated with structural, anatomic, or functional injury of one or 
both ovaries.
    Ovulation induction--See stimulated cycle.
    Ovulation drug--See stimulated cycle.
    Pregnancy test--A blood test which determines the level of human 
chorionic gonadotropin; if it is elevated this documents a pregnancy 
which can be biochemical, ectopic or clinical.
    Pregnancy reduction--A procedure in which the number of gestational 
sacs is reduced. It is used in women with multiple gestations, usually 
three or more, to decrease the number of fetuses a woman carries and 
improve the chances of survival of the remaining fetus(es) and the 
delivery of a healthy newborn(s).
    SART--Society for Assisted Reproductive Technology.
    Sperm--The male reproductive cell that has completed the process of 
meiosis and morphological differentiation.
    Sperm concentration--The number of sperm identified on microscopic 
examination per milliliter of ejaculate.
    Sperm donor--A man providing sperm for the fertilization procedures 
of a woman other than his sexual partner.
    Spontaneous abortion (miscarriage)--A pregnancy ending in 
spontaneous loss of the embryo or fetus prior to completion of 20 weeks 
of gestation.
    Stillbirth--Infant delivered without signs of life at 20 or greater 
weeks gestation.
    Stimulated cycle--An ART cycle in which a women receives ovarian 
stimulation, including the use of clomiphene citrate, follicle 
stimulating hormone, or human menopausal gonadotrophin (4).
    Thawed cycle--A cycle in which embryos previously frozen are thawed 
for embryo transfer.
    Therapeutic or induced abortion--Ending a pregnancy by using an 
operative procedure to electively terminate the pregnancy.
    Tubal factor--A factor causing reduced fecundity that is associated 
with structural, anatomic, or functional injury of one or both 
fallopian tubes.
    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 cause of infertility--Infertility in which a couple has 
received a comprehensive evaluation without identification of an 
etiology for the failure to conceive (7).
    Unstimulated cycle--An ART cycle in which the woman does not 
receive ovulation stimulation, except for the possible use of human 
chorionic gonadotropin. Instead, only natural follicular development 
occurs (3).
    Uterine factor--A factor causing reduced fecundity that is 
associated with structural, anatomic, or functional injury to the 
uterus.
    Zygote--A normal (2 pronuclei) fertilized egg before cell division 
begins (1).
    Zygote intra fallopian transfer (ZIFT)--Eggs are collected and 
fertilized, and the resulting zygote is then transferred to the 
fallopian tube (4).

III. Content of Published Reports

    These data can be used to provide a useful picture of the national 
rates of pregnancy in ART as well as clinic-specific rates (6). The 
annual report is expected to have two components:
    (1) A national component which will provide a comprehensive picture 
of success rates given a variety of factors including age, diagnosis, 
type of ART procedure, number of embryos transferred, etc. This is 
possible because the large number of cycles at the national level 
allows accurate statistical reporting of success rates, which is not 
possible with the smaller number of cycles carried out in individual 
clinics.
    (2) A clinic-specific component which will provide success rates 
for all assisted reproductive technologies using fresh embryos (IVF, 
GIFT, ZIFT, and combinations of these), success rates for cryopreserved 
embryos, success rates for donor embryos and the percentage of multiple 
pregnancies (twins and triplets or greater). An age-adjusted rate will 
be published with the 95 percent confidence interval. When numbers 
permit, success rates will also be reported by specific age groups. In 
addition, the clinic-specific component will provide other information 
which may be useful to the consumer, such as the number of cycles 
carried out, the percent distribution of types of ART, the types of 
infertility problems the clinic sees, and the average number of embryos 
transferred per cycle.
    Both components will be available to the general public. Pregnancy 
success rates will be defined and characterized as described below. The 
following information will be emphasized in the published annual 
reports. As resources allow, additional information may also be 
published in supplemental reports.
    1. The rate of live births after completion of ART according to the 
number of:
    a. All ovarian stimulation or monitoring procedures (cycle).
    b. Oocyte retrieval procedures.

[[Page 45263]]

    c. Embryo (or zygote, or oocyte) transfer procedures.
    2. Frequency of:
    a. Multiple gestations.
    b. Cancellations.
    3. The number of cycles carried out.
    4. The average number of embryos transferred per cycle.
    5. The rates in (1), (2a), and (4) will be categorized for:
    a. ART using fresh embryos, those using cryo-preserved embryos 
only, and those using donor oocytes.
    b. Age of woman at time of cycle (<35, 35-39 and >39).
    6. To aid in the interpretation of rates, the following information 
will be included:
    a. Clinic profile--What types of services the clinic offers (e.g., 
surrogacy, single women); the percentage of ART procedures which are 
IVF, GIFT, ZIFT; the percentage of procedures involving ICSI; the 
percentage of multiple pregnancies per transfer and the percentage of 
these multiple pregnancies which underwent selective reduction; and the 
percent distribution of causes of infertility.
    b. Consumer-oriented explanation of all medical and statistical 
terms used in the report.

References

1. American Fertility Society. IVF & GIFT. A Patient's Guide to 
Assisted Reproductive Technology. American Fertility Society. 
Birmingham, Alabama, 1989.
2. The Fertility Clinic Success Rate and Certification Act of 1992 
(Public Law 102-493).
3. American Fertility Society/Society for Reproductive Technology. 
Instructions for SART Data Collection System, 1993. American 
Fertility Society/Society for Assisted Reproductive Technology, 
Birmingham, Alabama, 1994.
4. American Fertility Society. Infertility: An Overview. A Guide for 
Patients. American Fertility Society, Birmingham, Alabama, 1994.
5. American Fertility Society. Investigation of the Infertile 
Couple. American Fertility Society, Birmingham, Alabama, 1991.
6. Wilcox LS, Peterson HB, Haseltine FP, Martin MC. Defining and 
Interpreting Pregnancy Success Rates for In Vitro Fertilization. 
Fertility and Sterility 1993; 60: 18-25.
7. Jones HW. On Reporting Pregnancies by Assisted Reproductive 
Technology. Fertility and Sterility 1993; 60: 759-761.
8. RESOLVE Assisted Reproductive Technologies Workbook RESOLVE, 
Inc., Boston, MA, 1994.

[FR Doc. 97-22611 Filed 8-25-97; 8:45 am]
BILLING CODE 4163-18-M