A Follow-up Study of Women Evaluated and Treated for Infertility
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility; Cancer
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Cancer Institute (NCI)
Summary
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.
Clinical Details
Official title: Follow-up Study of Women Evaluated and Treated for Infertility
Study design: N/A
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Stanford University, Stanford, California 94305-5584, United States
University of Illinois, Chicago, Illinois 60612, United States
Westat, Inc., Rockville, Maryland 20850, United States
Wayne State University Hutzel Hospital, Detroit, Michigan 48201, United States
Columbia University, New York, New York 10032-3784, United States
Additional Information
Starting date: June 1996
Last updated: June 10, 2008
|
