A 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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer, Melanoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Rectal Diseases Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

44 year–88 year

Sex eligibility

Female

Study type

Observational

Primary location

Columbia University

New York, 10032-3784, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Cancer

Time frame: ongoing

Breast, endometrial, ovarian, thyroid, melanoma

Secondary outcomes

Mortality

Time frame: Ongoing

All cause and cancer-specific death

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Follow-Up Study of Women Evaluated and Treated for Infertility

Important dates

Study start: 1995
Primary completion: 2012
Study completion: 2023
First posted: Jun 21, 2006
Registry last updated: Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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