Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS

Completed · Phase 4

Conditions studied: Polycystic Ovary Syndrome, Healthy, Anovulation, Hyperandrogenism

In brief

Women with PCOS suffer from anovulation and, as a result, infertility. Efforts to clinically induce ovulation in these women using follicle stimulating hormone (FSH) administered subcutaneously seemingly requires prolonged administration compared to that of ovulatory women without PCOS. The apparent differing ovarian responsiveness to FSH between PCOS and normal women has not been carefully studied. We propose to address this issue by performing a dose-response study and examine ovarian follicle (estrogen, E2) responses to FSH administered subcutaneously in women with PCOS compared to responses observed in normal women.

Key facts

Study ID: NCT03252223
Run by: University of California, San Diego
People needed: 33
Starts: 2017-10-02
Expected to finish: 2021-06-30
Last updated by the study team: 2021-09-08

Who can join

Age: 18 and older, up to 37. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Subjects determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound OR
Subjects determined to have a clinical history of regular periods.

You may not qualify if…

Women with hemoglobin less than 11 gm/dl at screening evaluation
Women with untreated thyroid abnormalities
Pregnant women or women who are nursing
Women with BMI > 37
Women with known sensitivity to the agents being used
Women with diabetes, or renal, liver, or heart disease
Women with any hormonal therapy or metformin for at least 2 months prior to study start.

Where it is running

University of California, San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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