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

January 9, 2024 updated by: National Cancer Institute (NCI)

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 Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

12193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - New York, New York, United States, 10032-3784
    - Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

44 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Subjects were enrolled based on treatment at fertility clinic.@@@

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Patients with Infertility Patients of all races with primary or secondary infertility, including women with recurrent miscarriages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Time Frame: ongoing	Breast, endometrial, ovarian, thyroid, melanoma	ongoing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Time Frame: Ongoing	All cause and cancer-specific death	Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Gretchen Benson, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 1995

Primary Completion (Actual)

December 31, 2012

Study Completion (Actual)

January 11, 2023

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria