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.

• 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.)
   

• 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:

• 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.
   

• 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.
   

• 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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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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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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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.

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:

• Clinics entered their data into an electronic data collection system and verified the data’s accuracy before sending the data to SART.

• SART compiled a national data set from the data submitted by individual clinics.

• CDC data analysts did comprehensive checks of the numbers reported for every clinic.

• Clinic tables, national figures, and accompanying text for both the printed and Internet versions were compiled and laid out.

• CDC and SART/ASRM reviewed the report.

• Necessary changes were incorporated and proofread.

• 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.

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.

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.

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.

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.

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.

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.

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.

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.

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*).

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.

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).

Overall, the content and format of this report are similar to those used in previous years. The following changes have been made:

• 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.

• 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.

• 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.