Official Title: “Follow-up Study of Women Evaluated and Treated for Infertility”

To assess the relations of infertility causes and treatment to cancer risk, we will conduct a retrospective cohort study of approximately 12,000 women evaluated for infertility between 1965-1988. These women will be ascertained from several large infertility clinics and private practices in various geographic locations in the United States: Boston, Chicago, Detroit, New York, and Palo Alto. These practices were selected on the basis of their having large number of patients who received ovulation stimulating drugs many years in the distant past. Abstractors reviewed clinic medical records to identify eligible study participants and abstract data needed to classify causes of infertility and document therapies employed.

Using a variety of tracing sources (including the National Death Index, credit bureaus, and postmasters), the vital status and location of the study subjects were determined. Subjects who were traced and identified as alive are being sent a detailed questionnaire that requests information on their health status as well as on a number of lifestyle practices. For subjects who report a cancer, medical verification is being sought from the diagnosing physicians and/or facilities. Death certificates are being sought for deceased subjects.

Study Type: Observational

Study Design: N/A

To assess the relations of infertility causes and treatment to cancer risk, we will conduct a retrospective cohort study of approximately 12,194 women evaluated for infertility between 1965-1988. These women will be ascertained from several large infertility clinics and private practices in diverse locations in the United States: Boston, Chicago, Detroit, New York, and Palo Alto. These practices were selected on the basis of their having large number of patients who received ovulation stimulating drugs many years in the distant past.

Abstractors reviewed clinic medical records to identify eligible study participants and abstract data needed to classify causes of infertility and document therapies employed.

Using a variety of tracing sources (including the National Death Index, credit bureaus, and postmasters), the vital status and location of the study subjects were determined. Subjects who were traced and identified as alive were sent a detailed questionnaire that requests information on their health status as well as on a number of lifestyle practices. For subjects who reported a cancer, medical verification was sought from the diagnosing physicians and/or facilities. Death certificates were sought for deceased subjects.

INCLUSION CRITERIA:

The following criteria for inclusion in the study cohort will apply:

• Patient is female.
• Patient was evaluated for infertility between (and including) 1965 and 1988.
• Patient had a U.S. address at the time of evaluation for infertility.
• Patient was seen twice by the physician, or was seen once but had a referral from another physician.
• Patient's infertility was not due to gonadal dysgenesis or congenital abnormalities of the reproductive system.
• Patient's visit to the infertility specialist was not to have a tubal ligation reversed.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Cancer Institute (NCI)

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00342446

Study ID Number: 999996019

ClinicalTrials.gov Identifier: NCT00342446

Health Authority: United States: Federal Government