A Follow-up Study of Women Evaluated and Treated for Infertility

Breast Cancer Clinical Trial

Official title:

Follow-Up Study of Women Evaluated and Treated for Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00342446
• Other study ID #: 999996019
• Secondary ID: OH96-C-N019
• Status: Completed
• Start date: October 1, 1995
• Est. completion date: January 11, 2023

Study information

• Verified date: January 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

BACKGROUND: We previously conducted a retrospective cohort study of 12,193 patients evaluated for infertility between 1960-1988 at five clinical sites. Detailed information abstracted from the medical records, along with questionnaires administered to located patients and cancer incidence and mortality data derived from cancer registries and the National Death Index, allowed us to examine cancer risk related to different causes of infertility and treatments while controlling for other patient characteristics. Although there were some increases of certain cancers related to various causes of infertility, we generally did not observe substantial relationships related to use of different fertility drugs. The one exception was some increased risk of uterine cancers with clomiphene use, of interest given the drug's chemical similarity to tamoxifen. Our numbers of patients with certain cancers (e.g., ovarian, uterine) were, however, limited and we had insufficient power to evaluate subgroup effects (e.g., drug relationships among nulligravid women).

OBJECTIVES: We therefore conducted an updated follow-up of these patients in order to assess cancer risk in relation to causes of infertility and therapeutic regimens used to treat these causes.

ELIGIBILITY: This study gained an additional 10 years of follow-up among the patients deemed eligible for the previous investigation. This included women with both primary and second infertility. Approximately 39% of the cohort previously were prescribed clomiphene citrate, while 10% received gonadotrophins.

DESIGN: Passive follow-up was attempted for patients who previously did not participate and for whom only information available in clinic records could be retained. All other patients were traced for active as well as passive follow-up. Active follow-up involved requesting that patients complete a short questionnaire, whereas passive follow-up was via linkage to cancer registries and the National Death Index. While cancer risks were assessed in relation to the general population, the majority of comparisons were internal ones, involving the calculation of relative risks (RRs) associated with different causes of infertility or treatment regimens while controlling for other cancer risk predictors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12193
• Est. completion date: January 11, 2023
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 44 Years to 88 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Infertility
• Ovarian Cancer
• Thyroid Cancer

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Atlas M, Menczer J. Massive hyperstimulation and borderline carcinoma of the ovary. A possible association. Acta Obstet Gynecol Scand. 1982;61(3):261-3. doi: 10.3109/00016348209156568. — View Citation

Bamford PN, Steele SJ. Uterine and ovarian carcinoma in a patient receiving gonadotrophin therapy. Case report. Br J Obstet Gynaecol. 1982 Nov;89(11):962-4. doi: 10.1111/j.1471-0528.1982.tb05067.x. No abstract available. — View Citation

Carter ME, Joyce DN. Ovarian carcinoma in a patient hyperstimulated by gonadotropin therapy for in vitro fertilization: a case report. J In Vitro Fert Embryo Transf. 1987 Apr;4(2):126-8. doi: 10.1007/BF01555453. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer	Breast, endometrial, ovarian, thyroid, melanoma	ongoing
Secondary	Mortality	All cause and cancer-specific death	Ongoing