Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
This multicenter, randomized, open-label exploratory study will be performed in approximately
200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro
fertilization (IVF). Each study center will follow its standard practice for in vitro
fertilization (IVF) within the study parameters as noted in this protocol. The study centers
will use marketed products purchased from Schraft's Pharmacy for all phases of the study
(down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be
randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim
Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil
for luteal support. Subjects will return to the study center for regular scheduled clinic
visits as required per in vitro fertilization (IVF) protocol at the site and at specified
times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and
first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic
gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at
completion of luteal support or negative serum pregnancy test following embryo transfer.