Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

PHASE4CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

September 30, 2010

Conditions
Polycystic Ovarian SyndromeInfertility
Interventions
DRUG

Menotropin

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.

DRUG

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.

DRUG

Follitropin beta

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.

DRUG

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.

DRUG

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.

Trial Locations (6)

10021

Weill Cornell Medical College, New York

33759

Women's Medical Research Group LLC, Florida, Clearwater

60610

Fertility Center of Illinois, Chicago

76022

Center for Assisted Reproduction, Bedford

80129

Conceptions Reproductive Associates of Colorado, Littleton

02905

Women & Infants' Hospital of RI, Providence

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY