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

NCT00342446 | Completed

• 2 other identifiers: 999996019OH96-C-N019
• Study Type: observational
• Target: 12,193
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Breast Cancer; Endometrial Cancer; Thyroid Cancer; Colorectal Cancer, Melanoma

Keywords

Gonadotropins; CLOMIPHENE; Ovulation-Stimulating Drugs; Natural History

Outcome Measures

Primary Outcomes (1)

• Cancer

  Breast, endometrial, ovarian, thyroid, melanoma

  ongoing

Secondary Outcomes (1)

• Mortality

  Ongoing

Study Arms (1)

Patients with Infertility

Patients of all races with primary or secondary infertility, including women with recurrent miscarriages.

Eligibility Criteria

• Age: 44 Years - 88 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Columbia University

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

Location

Related Publications (3)

• 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.

  PMID: 7171506 BACKGROUND

• 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.

  PMID: 3110335 BACKGROUND

• 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.

  PMID: 7124357 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Endometrial Neoplasms; Thyroid Neoplasms; Colorectal Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Gretchen Benson, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: October 1, 1995
• Primary Completion: December 31, 2012
• Study Completion: January 11, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

US (1)