33
Participants
Start Date
October 2, 2017
Primary Completion Date
June 30, 2021
Study Completion Date
June 30, 2021
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.
University of California, San Diego, La Jolla
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of California, San Diego
OTHER