110
Participants
Start Date
January 31, 2009
Primary Completion Date
July 31, 2010
Study Completion Date
September 30, 2010
Menotropin
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
Progesterone vaginal insert
100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.
Follitropin beta
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
Progesterone in oil
50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.
leuprolide acetate
Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
Weill Cornell Medical College, New York
Women's Medical Research Group LLC, Florida, Clearwater
Fertility Center of Illinois, Chicago
Center for Assisted Reproduction, Bedford
Conceptions Reproductive Associates of Colorado, Littleton
Women & Infants' Hospital of RI, Providence
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY