Status:
COMPLETED
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Polycystic Ovarian Syndrome
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
PHASE4
Brief Summary
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF)...
Eligibility Criteria
Inclusion
- Pre-menopausal females between the ages of 18 and 42 years
- Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies \[congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome\])
- Oligo- or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries
- Body mass index (BMI) of 18-39
- Early follicular phase (Day 3) 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., uncontrolled thyroid or adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, 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
- Two or more previous failed in vitro fertilization (IVF) cycles or in vitro fertilization (IVF)/assisted reproductive technology (ART) failure due to a poor response to gonadotropins, defined as development of 2 mature follicles
- History of recurrent pregnancy loss, defined as more than two clinical losses
- 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 \[TESE\])
- Prior hypersensitivity to any of the protocol drugs
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00805935
Start Date
January 1 2009
End Date
September 1 2010
Last Update
January 27 2012
Active Locations (6)
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1
Conceptions Reproductive Associates of Colorado
Littleton, Colorado, United States, 80129
2
Women's Medical Research Group LLC, Florida
Clearwater, Florida, United States, 33759
3
Fertility Center of Illinois
Chicago, Illinois, United States, 60610
4
Weill Cornell Medical College
New York, New York, United States, 10021