Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS

PHASE4CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

October 2, 2017

Primary Completion Date

June 30, 2021

Study Completion Date

June 30, 2021

Conditions
Polycystic Ovary SyndromeHealthyAnovulationHyperandrogenism
Interventions
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.

Trial Locations (1)

92037

University of California, San Diego, La Jolla

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of California, San Diego

OTHER

NCT03252223 - Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS | Biotech Hunter | Biotech Hunter