About the U.S. ART Clinic Reporting SystemBackground 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? 6. Why is the report of 2004 success rates being published in 2006? 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? 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 2004 report?
The latest data on infertility available to the Centers for Disease Control and Prevention (CDC) are from the 2002 National Survey of Family Growth.
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:
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
This law (
CDC contracts with a statistical survey research organization, Westat, to obtain the data published in the ART success rates report. Westat maintains a list of all ART clinics known to be in operation and tracks clinic reorganizations and closings. This list includes clinics and individual providers that are members of the Society for Assisted Reproductive Technology (SART) as well as clinics and providers that are not SART members. Westat actively follows up reports of ART physicians or clinics not on its list to update the list as needed. Westat maintains a Web-based data collection system called the National ART Surveillance System (NASS) that all ART clinics use. Clinics either electronically enter or import data into NASS 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 below (Why is the report of 2004 success rates being
published in 2006?) for a
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
Before success rates based on live births can be calculated, every ART
pregnancy must be
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. Then, Westat conducts an in-house review and contacts the clinics if corrections are necessary. After the data have been verified, a quality control process called validation begins. This year, 28 of 411 reporting clinics were selected for site visits. Two members of the Westat Validation Team visited these clinics and reviewed medical record data for a sample of the clinic’s ART cycles. For each cycle, the validation team abstracted information from the patient’s medical record. The abstracted information was then reviewed on site at Westat and compared 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
The data in both the national report and the individual fertility clinic reports come from 411 fertility clinics that provided and verified information about the outcomes of the ART cycles started in their clinics in 2004. Although we believe that almost all clinics that provided ART services in the United States throughout 2004 are represented in this report, data for a few clinics or practitioners are not included because they either were not in operation throughout 2004 or did not report as required. Clinics and practitioners known to have been in operation throughout 2004 that did not report and verify their data are listed in this report as nonreporters, as required by law (see Nonreporting ART Clinics for 2004, 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 122,977 cycles performed by the 411 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 239 ART cycles fell into this category in 2004.
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 2004 are represented in multiple cycles. Success rates cannot be calculated on a “per woman” basis because women’s names are not reported to Westat 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.
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,
Implementation of the Fertility Clinic Success Rate and Certification Act of 1992 Assisted Reproductive Technology: Embryo Laboratory Date last reviewed: 02/02/2007Content source: Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion |
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