[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
