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

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovarian Syndrome; Infertility

Intervention: Menotropin (Drug); Progesterone vaginal insert (Drug); Follitropin beta (Drug); Progesterone in oil (Drug); leuprolide acetate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ferring Pharmaceuticals

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3

Secondary outcome:

Number of Follicles Observed at Day 15

Number of Oocytes Retrieved at Day 18

Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved

Number of Embryos Transferred at Three Stages of Development Before Implantation

Number of Embryos Frozen

Percentage of Participants With Biochemical Pregnancy at Approximately Day 38

Percentage of Participants With Clinical Pregnancy at Week 7

Percentage of Participants With Ongoing Pregnancy at Week 9

Estradiol Levels at Day 6

Human Chorionic Gonadotropin (hCG) Levels at Day 6

Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration

Number of Live Births Resulting From the In Vitro Fertilization Process

Participants With Treatment Emergent Adverse Events

Eligibility

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 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

Locations and Contacts

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

Women's Medical Research Group LLC, Florida, Clearwater, Florida 33759, United States

Fertility Center of Illinois, Chicago, Illinois 60610, United States

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

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

Center for Assisted Reproduction, Bedford, Texas 76022, United States

Additional Information

Starting date: January 2009
Last updated: January 26, 2012

Page last updated: August 23, 2015

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