[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Notices]
[Pages 48402-48407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Draft: 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: Request for comments.

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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 Programs as required by the Fertility Clinic 
Success Rate and Certification Act of 1992 (FCSRCA). This Announcement 
supersedes, Announcement 97-226611 which was published in the Federal 
Register, August 26, 1997 (vol 62, no. 165).

DATES: To ensure consideration, written comments on this document must 
be received on or before October 4, 1999. Please do not FAX comments.

ADDRESSES: Comments shall be submitted to: Assisted Reproduction 
Technology Epidemiology Unit, 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, N.E., Atlanta, 
Georgia 30341-3724.

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 2b (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 2c (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 (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), 
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.
    This notice provides opportunity for public review and comment (see 
appendix).

    Dated: August 27, 1999.
Joseph R. Carter,
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. 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 assisted reproductive technology 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 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. 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 cost 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

[[Page 48403]]

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 1998 is 
January 15, 2000.) 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 reported on, i.e. the clinic was in operation after 
January 1, and failed to (a) submit a dataset to SART in the required 
software by the reporting deadline or (b) verify by signature of the 
medical director of the clinic, the clinic table 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 are 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, (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.
    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 1999 reporting system will include 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 and CDC accepted 
certification entity
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 a 
single donor are shared by multiple recipients
Total number of ART cycles performed during the reporting year

B. Patient Information

1. Patient Demographic Information
Ethnicity
Date of Birth
U.S. Resident
Zip Code
City of Residence
State of Residence
Country of Residence (if not U.S.)
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)

[[Page 48404]]

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)
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 Therapeutic Fetal Reduction Performed?
Therapeutic Reduction Date
Outcome of Pregnancy
    (Live birth, Stillbirth, Spontaneous Abortion, Therapeutic 
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 1999 (and later) reporting system:
    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 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 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 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

[[Page 48405]]

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.
    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 therapeutic 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 therapeutic 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 which 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, 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 which 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 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 which 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.

[[Page 48406]]

    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 which 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.
    Hydrosalpinx--Accumulation of watery fluid in a fallopian tube 
which usually represents 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).
    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 which 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 
(host uterus) 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).
    Therapeutic or induced abortion--Operative procedure to electively 
terminate the entire pregnancy (no gestational age limit).
    Therapeutic reduction--A procedure in which the number of fetal 
sacs is

[[Page 48407]]

reduced by direct medical intervention. Termination of an ectopic 
gestation or a heterotopic pregnancy is not considered a therapeutic 
reduction. Therapeutic reduction is used in women with multiple 
gestations, usually three or more, to decrease the number of fetuses a 
woman carries usually to two.
    Tubal embryo transfer (TET)--Transfer of an early stage embryo to 
the fallopian tube.
    Tubal factor--A factor causing reduced fecundity that is associated 
with structural, anatomic, or functional injury of one or both 
fallopian tubes; the following are included: (1) tubal ligation, not 
reversed; (2) hydrosalpinx (in place); (3) 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 citrate 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.

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 which 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 which 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.
    The entire annual report will be available to the general public. 
As resources allow, additional information may also be published.

[FR Doc. 99-22868 Filed 9-2-99; 8:45 am]
BILLING CODE 4160-18-P