Clinical trial · Interventional
Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS
Ovarian Function in Women With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anovulation | — | UNRESOLVED | — |
| Healthy | — | UNRESOLVED | — |
| Hyperandrogenism | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Follicle Stimulating Hormone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Women with normal menses
- interventionNames
- Drug: Recombinant Follicle Stimulating Hormone
- type
- ACTIVE_COMPARATOR
- label
- Women with Polycystic Ovary Syndrome
- interventionNames
- Drug: Recombinant Follicle Stimulating Hormone
Primary outcomes (3)
- measure
- Change in granulosa cell function in 24 hours intervals following FSH administration
- timeFrame
- Serum levels will be assessed daily during each 3 day FSH stimulation test and for five days following the initial FSH administration
- description
- Granulosa function will be assessed using estradiol and inhibin levels
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 37 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available