Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
Condition: Polycystic Ovarian Syndrome; Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Intervention: Menotropin; Progesterone vaginal insert; Follitropin beta; Progesterone in oil; leuprolide acetate
Intervention description: 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.; 100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.; 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.; 50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.; Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
Intervention MeSH terms: Leuprolide; Menotropins; Progesterone; Follicle Stimulating Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: pre-menopausal women; PCOS; polycystic ovarian syndrome; infertility; IVF; in vitro fertilization

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). Each study center will follow its 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 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
      times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and
      first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic
      gonadotropin (hCG) labs. 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. 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

          3. Body mass index (BMI) of 18-39

          4. Early follicular phase (Day 3) follicle stimulating hormone (FSH) < 15 IU/L and
             estradiol (E2) within normal limits

          5. 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.)

          6. Transvaginal ultrasound at screening consistent with findings adequate for assisted
             reproductive technology (ART) with respect to uterus and adnexa

          7. Signed informed consent

        Exclusion Criteria:

          1. Gestational or surrogate carrier, donor oocyte

          2. 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)

          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. 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

          5. History of recurrent pregnancy loss, defined as more than two clinical losses

          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])

         11. Prior hypersensitivity to any of the protocol drugs