[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
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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