Status:
COMPLETED
MENOPUR® Versus FOLLISTIM®
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
PHASE4
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 i...
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 cente...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 \[TESE\])
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00802360
Start Date
December 1 2008
End Date
January 1 2010
Last Update
November 2 2011
Active Locations (7)
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1
Huntington Reproductive Center
Pasadena, California, United States, 91105
2
San Diego Fertility Center
San Diego, California, United States, 92130
3
Conceptions Reproductive Associates of Colorado
Littleton, Colorado, United States, 80129
4
Women's Medical Research Group, LLC
Clearwater, Florida, United States, 33759