Clinical trial NCT00802360: MENOPUR® Versus FOLLISTIM®
Official title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Pre-menopausal females between the ages of 18 and 42 years
2. Body mass index (BMI) of 18-34
3. Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) \<15 IU/L and Estradiol (E2) within normal limits
4. Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women \>38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
5. Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
6. Signed informed consent

Exclusion Criteria:

1. Gestational or surrogate carrier, donor oocyte
2. Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
3. Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
4. Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of \>2 previous failed in vitro fertilization (IVF) cycles.
5. History of recurrent pregnancy loss (\>2).
6. Presence of abnormal uterine bleeding of undetermined origin
7. Current or recent substance abuse, including alcohol or smoking \>10 cigarettes per day
8. Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
9. Participation in any experimental drug study within 30 days prior to Screening
10. Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration \[MESA\], testicular sperm extraction \[TESE\])

Primary outcomes:
measure: Percentage of Participants With Ongoing Pregnancy at Week 8
timeFrame: Week 8 (Week 6 of gestation)
Secondary outcomes:
measure: Number of Follicles Observed at Day 15
timeFrame: Day 15
measure: Number of Oocytes Retrieved at Day 18
timeFrame: Approximately Day 18
measure: Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
timeFrame: Approximately Day 19
measure: Number of Embryos Transferred at Three Stages of Development
timeFrame: Approximately Day 24
measure: Number of Embryos Frozen at Day 24
timeFrame: Approximately Day 24
measure: Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
timeFrame: Day 1 to Day 24
measure: Participants With Biochemical Pregnancy at Day 38
timeFrame: approximately day 38 (Day 14 post embryo transfer)
measure: Participants With Clinical Pregnancy at Week 7
timeFrame: approximately week 7
measure: Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: Day 1 - week 12
measure: Number of Live Births
timeFrame: Approximately 10 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Reproductive Center
state: California
city: San Diego
country: United States
facility: San Diego Fertility Center
state: California
city: Littleton
country: United States
facility: Conceptions Reproductive Associates of Colorado
state: Colorado
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Naperville
country: United States
facility: The Advanced IVF Institute; Charles E. Miller, MD & Associates
state: Illinois
city: Baton Rouge
country: United States
facility: A Woman's Center for Reproductive Medicine
state: Louisiana
city: Bedford
country: United States
facility: Center for Assisted Reproduction
state: Texas
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: