Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS
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ClinicalTrials.gov Identifier: NCT03252223 |
Recruitment Status :
Completed
First Posted : August 17, 2017
Last Update Posted : September 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome Healthy Anovulation Hyperandrogenism | Drug: Recombinant Follicle Stimulating Hormone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Ovarian Function in Women With Polycystic Ovary Syndrome |
Actual Study Start Date : | October 2, 2017 |
Actual Primary Completion Date : | June 30, 2021 |
Actual Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Women with normal menses |
Drug: Recombinant Follicle Stimulating Hormone
A modified dose-response study will be done using recombinant FSH (r-FSH), injected sc for 3 days at any one dose. r-FSH will be administered at weight-adjusted doses equivalent to 37.5, 75, and 150 IU based on an average weight of 70 kg, which approximates the weight of the average woman in the United States according to the Centers for Disease Control. Therefore, the actual dose of r-FSH will be 0.53 IU/kg for the 37.5 dose group. Accordingly, r-FSH will be repeated at doses of 1.1 IU/kg and 2.2 IU/kg that are equivalent to 75 and 150 IU for a 70 kg subject. Each FSH stimulation test will be assigned randomly and be separated by an interval of 8 weeks. |
Active Comparator: Women with Polycystic Ovary Syndrome |
Drug: Recombinant Follicle Stimulating Hormone
A modified dose-response study will be done using recombinant FSH (r-FSH), injected sc for 3 days at any one dose. r-FSH will be administered at weight-adjusted doses equivalent to 37.5, 75, and 150 IU based on an average weight of 70 kg, which approximates the weight of the average woman in the United States according to the Centers for Disease Control. Therefore, the actual dose of r-FSH will be 0.53 IU/kg for the 37.5 dose group. Accordingly, r-FSH will be repeated at doses of 1.1 IU/kg and 2.2 IU/kg that are equivalent to 75 and 150 IU for a 70 kg subject. Each FSH stimulation test will be assigned randomly and be separated by an interval of 8 weeks. |
- Change in granulosa cell function in 24 hours intervals following FSH administration [ Time Frame: Serum levels will be assessed daily during each 3 day FSH stimulation test and for five days following the initial FSH administration ]Granulosa function will be assessed using estradiol and inhibin levels
- Change in follicle count in following FSH administration [ Time Frame: With each dose tested, a pelvic ultrasound will be done before and 3 days after commencing FSH ]Number of ovarian follicles will be assessed by pelvic ultrasound
- Change in follicular size in following FSH administration [ Time Frame: With each dose tested, a pelvic ultrasound will be done before and 3 days after commencing FSH ]Size of ovarian follicles will be assessed by pelvic ultrasound

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Ages Eligible for Study: | 18 Years to 37 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252223
United States, California | |
University of California, San Diego | |
La Jolla, California, United States, 92037 |
Principal Investigator: | R. Jeffrey Chang, MD | University of California, San Diego |
Responsible Party: | Jeffrey Chang, MD, Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03252223 |
Other Study ID Numbers: |
170684 P50HD012303 ( U.S. NIH Grant/Contract ) K12HD001259 ( U.S. NIH Grant/Contract ) |
First Posted: | August 17, 2017 Key Record Dates |
Last Update Posted: | September 8, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
polycystic ovary syndrome anovulation hyperandrogenism |
Polycystic Ovary Syndrome Hyperandrogenism Anovulation Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases |
Gonadal Disorders Endocrine System Diseases 46, XX Disorders of Sex Development Disorders of Sex Development Urogenital Abnormalities Adrenogenital Syndrome Congenital Abnormalities Hormones Follicle Stimulating Hormone Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |