MENOPUR® Versus FOLLISTIM®

Completed · Phase 4

Conditions studied: Infertility

In brief

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

Key facts

Study ID

NCT00802360

Run by

Ferring Pharmaceuticals

People needed

173

Starts

2008-12-01

Expected to finish

2010-01-01

Last updated by the study team

2011-11-02

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pre-menopausal females between the ages of 18 and 42 years
• Body mass index (BMI) of 18-34
• Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) <15 IU/L and Estradiol (E2) within normal limits
• 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.)
• Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
• Signed informed consent

You may not qualify if…

• Gestational or surrogate carrier, donor oocyte
• Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
• 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
• 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.
• History of recurrent pregnancy loss (>2).
• Presence of abnormal uterine bleeding of undetermined origin
• Current or recent substance abuse, including alcohol or smoking >10 cigarettes per day
• Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
• Participation in any experimental drug study within 30 days prior to Screening
• Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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