A Follow-up Study of Women Evaluated and Treated for Infertility
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|ClinicalTrials.gov Identifier: NCT00342446|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : November 9, 2018
|First Submitted Date||June 19, 2006|
|First Posted Date||June 21, 2006|
|Last Update Posted Date||November 9, 2018|
|Study Start Date||June 5, 1996|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Cancer [ Time Frame: ongoing ]
Breast, endometrial, ovarian, thyroid, melanoma
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00342446 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||A Follow-up Study of Women Evaluated and Treated for Infertility|
|Official Title||Follow-Up Study of Women Evaluated and Treated for Infertility|
|Brief 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.|
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 Design||Observational Model: Cohort
Time Perspective: Retrospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Subjects were enrolled based on treatment at fertility clinic.@@@|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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.
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999996019
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor||National Cancer Institute (NCI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 5, 2018|