2001 Assisted Reproductive Technology (ART) Report: Commonly Asked
Questions |
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About the U.S. ART Clinic Reporting System
Background
Information, Data Collection Methods, Content and Design of the Report,
and Additional Information About ART in the United States
1. How
many people in the United States have infertility problems?
2.
What is assisted reproductive technology (ART)?
3.
What is the 1992 Fertility Clinic Success Rate and Certification Act?
4. How
do U.S. ART clinics report data to CDC about their success rates?
5.
What is an ART cycle?
6. Why
is the report of 2001 success rates being published in 2003?
7.
What quality control steps are used to ensure data accuracy?
8.
Which clinics are represented in this report?
9.
Does this report include all ART cycles performed by the reporting
clinics?
10.
How are the success rates determined?
11.
If a woman has had more than one ART treatment cycle, how is the success
rate calculated?
12.
What factors that influence success rates are presented in this report?
13.
Why doesn’t the report contain specific medical information about ART?
14.
Does CDC have any information on the age, race, income, and education
levels of women who donate eggs?
15.
Are there any medical guidelines for ART performed in the United States?
16.
What is CDC doing to ensure that the report is helpful to the public?
17.
Where can I get additional information on U.S. fertility clinics?
18.
What’s new in the 2001 report?
1. How many people
in the United States have infertility problems?
The latest
data on infertility available to CDC are from the 1995 National Survey of
Family
Growth.
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Of the
approximately 60 million women of reproductive age in 1995, about 1.2
million, or 2%, had had an infertility-related medical appointment
within the previous year and an additional 13% had received infertility
services at some time in their lives. (Infertility services include
medical tests to diagnose infertility, medical advice and treatments to
help a woman become pregnant, and services other than routine prenatal
care to prevent miscarriage.)
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Additionally, 7% of married couples in which the woman was of
reproductive age (2.1 million couples) reported they had not used
contraception for 12 months and the woman had not become pregnant.
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2. What is
assisted reproductive technology (ART)?
Although
various definitions have been used for ART, the definition used in this
report is based on the 1992 law that requires CDC to publish this report.
According to this definition, ART includes all fertility treatments in
which both eggs and sperm are handled. In general, ART procedures involve
surgically removing eggs from a woman’s ovaries, combining them with sperm
in the laboratory, and returning them to the woman’s body or donating them
to another woman. They do NOT include treatments in which only sperm are
handled (i.e., intrauterine—or artificial—insemination) or procedures in
which a woman takes drugs only to stimulate egg production without the
intention of having eggs retrieved.
The types
of ART include the following:
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IVF (in
vitro fertilization). Involves extracting a woman’s eggs, fertilizing
the eggs in the laboratory, and then transferring the resulting embryos
into the woman’s uterus through the cervix. For some IVF procedures,
fertilization involves a specialized technique known as intracytoplasmic
sperm injection (ICSI). In ICSI a single sperm is injected directly into
the woman’s egg.
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GIFT
(gamete intrafallopian transfer). Involves using a fiber-optic
instrument called a laparoscope to guide the transfer of unfertilized
eggs and sperm (gametes) into the woman’s fallopian tubes through small
incisions in her abdomen.
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ZIFT
(zygote intrafallopian transfer). Involves fertilizing a woman’s eggs in
the laboratory and then using a laparoscope to guide the transfer of the
fertilized eggs (zygotes) into her fallopian tubes. In addition, ART
often is categorized according to whether the procedure used a woman’s
own eggs (nondonor) or eggs from another woman (donor) and according to
whether the embryos used were newly fertilized (fresh) or
previously fertilized, frozen, and then thawed (frozen). Because an ART
procedure includes several steps, it is typically referred to as a cycle
of
treatment. (See What is an ART cycle? )
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3. What
is the 1992 Fertility Clinic Success Rate and Certification Act?
This law
(Fertility Clinic Success Rate and Certification Act of 1992,
http://www.phppo.cdc.gov/dls/art/fcsrca_9907.asp, [FCSRCA],
Section 2 [a] of P.L. 102-493 [42 U.S.C. 263 (a) -1]), which the U.S.
Congress passed in 1992, requires all clinics performing ART in the United
States to annually report their success rate data to CDC. CDC uses the
data to publish an annual report detailing the ART success rates for each
of these clinics.
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4. How
do U.S. ART clinics report data to CDC about their success rates?
CDC
contracts with a professional society, the Society for Assisted
Reproductive Technology (SART), to obtain the data published each
year in the ART success rates report. SART is an organization of ART
providers affiliated with the American Society for Reproductive Medicine (ASRM).
SART maintains a list of all ART clinics known to be in operation in each
year and tracks clinic reorganizations and closings. This list includes
clinics and individual providers that are members of SART as well as
clinics and providers that are not SART members. SART actively follows up
reports of ART physicians or clinics not on its list to update the list as
needed. Each year SART distributes a standard database-management software
system and instructions to all ART clinics. Clinics electronically enter
data into the SART system for each ART procedure they start in a given
reporting year. The data collected include information on the client’s
medical history (such as infertility diagnoses), clinical information
pertaining to the ART procedure, and information on resulting pregnancies
and births.
See (Why
is the report of 2001 success rates being published in 2003?) for
a complete description of the reporting process.
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5. What is
an ART cycle?
Because ART
consists of several steps over an interval of approximately 2 weeks, an
ART procedure is more appropriately considered a cycle of
treatment rather than a procedure at a single point in time. The start of
an ART cycle is considered to be when a woman begins taking drugs to
stimulate egg production or starts ovarian monitoring with the intent of
having embryos transferred. (See Figure 3,
for a full description of the steps in an ART cycle.) For the purposes of
this report, data on all cycles that were started, even
those that were discontinued before all steps were undertaken, are
submitted to CDC through SART and are counted in the clinic’s success
rates.
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6. Why
is the report of 2001 success rates being published in 2003?
Before success rates based on
live births can be calculated, every ART pregnancy must be followed up to
determine whether a birth occurred. Therefore, the earliest that clinics
can report complete annual data is late in the year after ART treatment
was initiated (about 9 months past year-end, when all the births have
occurred). Accordingly, the results of all the cycles initiated in 2001
were not known until October 2002. After ART outcomes were known, the
following steps had to be completed before the report could be published:
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Clinics entered their data
into an electronic data collection system and verified the data’s
accuracy before sending the data to SART.
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SART compiled a national
data set from the data submitted by individual clinics.
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CDC data analysts did
comprehensive checks of the numbers reported for every clinic.
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Clinic tables, national
figures, and accompanying text for both the printed and Internet
versions were compiled and laid out.
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CDC and SART/ASRM reviewed
the report.
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Necessary changes were
incorporated and proofread.
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The report was submitted to
the Government Printing Office to begin the printing and production
process.
These steps are
time-consuming but essential for ensuring that the report provides the
public
with correct information and does not misrepresent any clinic’s success
rates.
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7. What
quality control steps are used to ensure data accuracy?
To have their success rates
published in this annual report, clinics have to submit their data in time
for analysis and the clinics’ medical directors have to verify by
signature that the tabulated success rates are accurate. After the data
have been verified, a quality control process called validation begins.
This year, 40 of 384 reporting clinics were selected for site visits. Two
members of the SART Validation Committee visited these clinics and
compared medical record data for a sample of the clinic’s ART cycles with
the data submitted for the report. CDC staff members participated as
observers in some of the visits. For each clinic, the sample of cycles
validated included all cycles that were reported to have ended in a live
birth and a random sample of up to 50 additional cycles. In almost all
cases, data on pregnancies and births in the medical records were
consistent with reported data. Validation primarily helps ensure that
clinics are being careful to submit accurate data. It also serves to
identify any systematic problems that could cause data collection to be
inconsistent or incomplete.
The data validation process
does not include any assessment of clinical practice or overall record
keeping. See Appendix A, Technical Notes, for a
more detailed presentation of
findings from
the validation visits.
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8.
Which clinics are represented in this report?
The data in
both the national report and the individual fertility clinic reports come
from 384 fertility clinics that provided and verified information about
the outcomes of the ART cycles started in their clinics in 2001.
Although we
believe that almost all clinics that provided ART services in the United
States throughout 2001 are represented in this report, data for a few
clinics or practitioners are not included because they either were not in
operation throughout 2001 or did not report as required. Clinics and
practitioners known to have been in operation throughout 2001 that did not
report and verify their data are listed in this report as nonreporters, as
required by law (see Nonreporting ART
Clinics for 2001, by State). We will continue to make every effort to
include in future reports all clinics and practitioners providing ART
services.
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9. Does
this report include all ART cycles performed by the reporting clinics?
This report
includes data for the 107,587 cycles performed by the 384 clinics that
reported their data as required. A small number of ART cycles are not
included in either the national data or the individual fertility clinic
tables. These were cycles in which a new treatment procedure was being
evaluated. Only 82 ART cycles fell into this category in 2001.
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10. How
are the success rates determined?
Three
measures of success are presented in this report: (1) pregnancy, (2)
birth of one or more living infants (the delivery of multiple infants
is counted as one live birth), and (3) birth of a singleton live-born
infant. The pregnancies reported here were diagnosed using an
ultrasound procedure. All live-birth deliveries were reported to the ART
physician by either the patient or her obstetric provider. Because this
report is geared toward patients, the focus is on live birth rates.
Singleton live births are presented as a separate measure of success
because they have a much lower risk than multiple-infant births for
adverse infant health outcomes, including prematurity, low birth weight,
disability, and death. Pregnancy, live birth rates, and singleton live
birth rates were calculated based on all cycles started. As
noted throughout the report, success rates were additionally calculated at
various steps of the ART cycle to provide a complete picture of the
chances for success as the cycle progresses.
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11. If a
woman has had more than one ART treatment cycle, how is the success
rate calculated?
As required
by law, this report presents ART success rates in terms of cycles started
each year rather than in terms of women. (A cycle starts when a woman
begins taking fertility drugs or having her ovaries monitored for follicle
production.) Therefore, women who had more than one ART cycle started in
2001 are represented in multiple cycles. Success rates cannot be
calculated on a “per woman” basis because women’s names are not reported
to SART and CDC.
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12. What
factors that influence success rates are presented in this report?
The
national report presents a more in-depth picture of ART than can be shown
for each individual clinic. Success rates are presented in the context of
various patient and treatment characteristics that may influence success.
These characteristics include age, infertility diagnosis, history of
previous births, previous miscarriages, previous ART cycles, number of
embryos transferred, type of ART procedure, use of techniques such as ICSI,
and clinic size.
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13. Why
doesn’t the report contain specific medical information about ART?
This report
describes a woman’s average chances of success using ART. Although the
report provides some information about factors such as age and infertility
diagnosis, individual couples face many unique medical situations. This
population-based registry of ART procedures cannot capture detailed
information about specific medical conditions associated with infertility.
A physician in clinical practice should be consulted for the individual
evaluation that will help a woman or couple understand their specific
medical situation and their chances of success using ART.
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14.
Does CDC have any information on the age, race, income, and education
levels of women who donate eggs?
CDC does
not collect information on egg donors beyond what is presented in this
report. Success rates for cycles using donor eggs or using embryos derived
from donor eggs are presented separately based on the ART patient’s age.
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15. Are
there any medical guidelines for ART performed in the United States?
ASRM and
SART issue guidelines dealing with specific ART practice issues, such
as the number of embryos to be transferred in an ART procedure. Further
information can be obtained from ASRM or SART (both at telephone
205-978-5000 or Web sites http://www.asrm.org*
and http://www.sart.org*).
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16.
What is CDC doing to ensure that the report is helpful to the public?
We
continually review comments from patients and providers on issues to
consider for future reports. In 1999 CDC held focus groups of people who
were either considering or undergoing ART in four cities in different
areas of the country. The groups generally were satisfied with both the
format and content of the report. They suggested specific ways to improve
the report and additional information to include. Many of these changes
have been incorporated into the annual report.
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17.
Where can I get additional information on U.S. fertility clinics?
For further
information on specific clinics, contact the clinic directly. In addition,
SART* can provide general information on
its member clinics (telephone 205-978-5000, extension 109).
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18.
What’s new in the 2001 report?
Overall,
the content and format of this report are similar to those used in
previous years. The following changes have been made:
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We have
included an additional measure of success, singleton live birth rates.
Singleton live births are an important measure of success because they
have a much lower risk than multiple-infant births for adverse infant
health outcomes, including prematurity, low birth weight, disability, and
death. The national report presents singleton live births per cycle
started and singleton live births per embryo transfer. Singleton live
birth per transfer rates also have been included in all clinic tables.
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This year’s
report also includes added information on gestational carrier cycles. Each
clinic table now lists the percentage of fresh–nondonor cycles started in
2001 that used gestational carriers (surrogates). Additionally, these
cycles are included in all of the statistics presented in the national and
clinic tables, whereas in previous years’ reports these cycles were
excluded from table statistics.
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Section 5
of the national report (ART Trends, 1996–2001) includes the addition of
trends in singleton live births per transfer by type of ART procedure,
trends in singleton live births per transfer by woman’s age, and trends in
multiple births.
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Links to non-Federal organizations found at this site are provided solely as a service to our users. These links do not constitute an endorsement of these organizations or their programs by CDC or the Federal Government, and none should be inferred. The CDC is not responsible for the content of the individual organization Web pages found at these links. |
Previous ART Reports
Implementation of the Fertility
Clinic Success Rate and Certification Act of 1992
Assisted Reproductive Technology: Embryo
Laboratory
Date last reviewed:
03/23/2006
Content source: Division
of Reproductive Health,
National Center for Chronic Disease
Prevention and Health Promotion
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