Healthy Clinical Trial
Official title:
Ovarian Function in Women With Polycystic Ovary Syndrome
Verified date | September 2021 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 37 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in granulosa cell function in 24 hours intervals following FSH administration | Granulosa function will be assessed using estradiol and inhibin levels | Serum levels will be assessed daily during each 3 day FSH stimulation test and for five days following the initial FSH administration | |
Primary | Change in follicle count in following FSH administration | Number of ovarian follicles will be assessed by pelvic ultrasound | With each dose tested, a pelvic ultrasound will be done before and 3 days after commencing FSH | |
Primary | Change in follicular size in following FSH administration | Size of ovarian follicles will be assessed by pelvic ultrasound | With each dose tested, a pelvic ultrasound will be done before and 3 days after commencing FSH |
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