MENOPUR® Versus FOLLISTIM®
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Menotropin (Drug); Progestrone vaginal insert (Drug); follitropin beta (Drug); Progesterone in oil (Drug); Ganirelix (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
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
Clinical Details
Official title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Ongoing Pregnancy at Week 8
Secondary outcome: Number of Follicles Observed at Day 15Number of Oocytes Retrieved at Day 18 Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved Number of Embryos Transferred at Three Stages of Development Number of Embryos Frozen at Day 24 Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle Participants With Biochemical Pregnancy at Day 38 Participants With Clinical Pregnancy at Week 7 Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS) Number of Live Births
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
Minimum age: 18 Years.
Maximum age: 42 Years.
Gender(s): Female.
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])
Locations and Contacts
Huntington Reproductive Center, Pasadena, California 91105, United States
San Diego Fertility Center, San Diego, California 92130, United States
Conceptions Reproductive Associates of Colorado, Littleton, Colorado 80129, United States
Women's Medical Research Group, LLC, Clearwater, Florida 33759, United States
The Advanced IVF Institute; Charles E. Miller, MD & Associates, Naperville, Illinois 60540, United States
A Woman's Center for Reproductive Medicine, Baton Rouge, Louisiana 70815, United States
Center for Assisted Reproduction, Bedford, Texas 76022, United States
Additional Information
Starting date: December 2008
Last updated: October 31, 2011
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