Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

Condition(s) targeted: Polycystic Ovarian Syndrome; Infertility

Intervention: Menopur® (Drug); Endometrin® (Drug); Follistim Pen® (Drug); Progesterone in oil (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Overall contact:
Clinical Development Support, Email: DK0-Disclosure@ferring.com

This multicenter, randomized, open-label exploratory study will be performed in approximately 200 PCOS but otherwise healthy females undergoing IVF. Each study center will follow its standard practice for 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 Menopur® or Follistim Pen® for stimulation and Endometrin® or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per IVF protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of hCG, and first serum pregnancy test) for estradiol (E2), progesterone (P4) and 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.

Official title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Rate of cycle cancellation due to risk of ovarian hyperstimulation syndrome (OHSS).

Secondary outcome:

Number of Follicles

Number of oocytes retrieved

Fertilization rate

Implantation rate

Embryo quality

Number of embryos frozen

Biochemical pregnancy rate

Clinical pregnancy rate

Ongoing Pregnancy Rate

Hormone levels during cycle (estradiol, hCG, progesterone)

Live birth rate

Adverse events, including ovarian hyperstimulation syndrome (OHSS)

Minimum age: 18 Years. Maximum age: 42 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

1. Pre-menopausal females between the ages of 18 and 42 years

2. Diagnosed with 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) 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 IVF cycles or IVF/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

Clinical Development Support, Email: DK0-Disclosure@ferring.com

Conceptions Reproductive Associates of Colorado, Littleton, Colorado 80129, United States; Recruiting

Georgia Reproductive Specialists, Atlanta, Georgia 30342, United States; Recruiting

Fertility Centers of Illinois, Chicago, Illinois 60610, United States; Recruiting

Weill Cornell Medical College, New York, New York 10021, United States; Recruiting

Center for Women's Reproductive Care-Columbia University, New York, New York 10019, United States; Withdrawn

Women & Infants' Hospital of RI, Providence, Rhode Island 02905, United States; Recruiting

Starting date: January 2009
Ending date: August 2010
Last updated: May 20, 2009