Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Follicle Stimulating Hormone; Hormones

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Women with hemoglobin less than 11 gm/dl at screening evaluation

2. Women with untreated thyroid abnormalities

3. Pregnant women or women who are nursing

4. Women with BMI > 37

5. Women with known sensitivity to the agents being used

6. Women with diabetes, or renal, liver, or heart disease

7. Women with any hormonal therapy or metformin for at least 2 months prior to study start.