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A Follow-up Study of Women Evaluated and Treated for Infertility
This study has been completed.
First Received: June 19, 2006   Last Updated: November 25, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00342446
  Purpose

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.


Condition
Infertility
Cancer

Study Type: Observational
Official Title: Follow-up Study of Women Evaluated and Treated for Infertility

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: June 1996
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00342446

Locations
United States, California
Stanford University
Stanford, California, United States, 94305-5584
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60612
United States, Michigan
Wayne State University Hutzel Hospital
Detroit, Michigan, United States, 48201
United States, New York
Columbia University
New York, New York, United States, 10032-3784
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: 999996019, OH96-C-N019
Study First Received: June 19, 2006
Last Updated: November 25, 2009
ClinicalTrials.gov Identifier: NCT00342446     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Clomid
Breast Cancer
Ovarian Cancer
Ovulation Induction
Pergonal

Additional relevant MeSH terms:
Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on February 08, 2010