To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow its study center 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 prior to the start of stimulation 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 time periods during the cycle for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) tests, and first serum pregnancy test. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
173
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.
100 mg progesterone vaginal insert 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.
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.
Huntington Reproductive Center
Pasadena, California, United States
San Diego Fertility Center
San Diego, California, United States
Conceptions Reproductive Associates of Colorado
Littleton, Colorado, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Percentage of Participants With Ongoing Pregnancy at Week 8
The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.
Time frame: Week 8 (Week 6 of gestation)
Number of Follicles Observed at Day 15
The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
Time frame: Day 15
Number of Oocytes Retrieved at Day 18
The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.
Time frame: Approximately Day 18
Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.
Time frame: Approximately Day 19
Number of Embryos Transferred at Three Stages of Development
The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.
Time frame: Approximately Day 24
Number of Embryos Frozen at Day 24
The number of embryos that were not transferred but instead were frozen for future use.
Time frame: Approximately Day 24
Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
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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.
Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
The Advanced IVF Institute; Charles E. Miller, MD & Associates
Naperville, Illinois, United States
A Woman's Center for Reproductive Medicine
Baton Rouge, Louisiana, United States
Center for Assisted Reproduction
Bedford, Texas, United States
Time frame: Day 1 to Day 24
Participants With Biochemical Pregnancy at Day 38
Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.
Time frame: approximately day 38 (Day 14 post embryo transfer)
Participants With Clinical Pregnancy at Week 7
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Time frame: approximately week 7
Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale: mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable. Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.
Time frame: Day 1 - week 12
Number of Live Births
Time frame: Approximately 10 months