drugset / Trial / NCT03252223
Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS
Phase 4
Completed
33 enrolled
University of California, San Diego
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
Non-randomizedParallel-groupOpen-labelOther
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.
Timeline
- Start
- 2017-10-02
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gonal-f | Protein / enzyme biologic | 0.53 iu/kg | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 1.1 iu/kg | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 2.2 iu/kg | Subcutaneous |