MENOPUR® Versus FOLLISTIM®
Condition: Infertility
MeSH terms: Infertility
Intervention: Menotropin; Progestrone vaginal insert; follitropin beta; Progesterone in oil; Ganirelix
Intervention description: 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.; 100 mg progesterone vaginal insert 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 until human chorionic gonadotropin (hCG) criteria are met.; 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.; Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
Intervention MeSH terms: Menotropins; Progesterone; Follicle Stimulating Hormone; Ganirelix
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF

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
    

Eligibility 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])