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NCT Number: NCT00805935

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

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.

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Key information

Conditions

Polycystic Ovarian Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

menotropin

Drug

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.

Other names: Menopur®

Progesterone vaginal insert

Drug

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.

Other names: Endometrin®

Follitropin beta

Drug

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.

Other names: Follistim Pen®

Progesterone in oil

Drug

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.

Leuprolide Acetate

Drug

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.

Other names: Lupron

Primary outcomes

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

    Time frame: weeks 1-3

    A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).

Secondary outcomes

  1. Number of Follicles Observed at Day 15

    Time frame: approximately day 15

    The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.

  2. Number of Oocytes Retrieved at Day 18

    Time frame: approximately day 18

    The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.

  3. Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved

    Time frame: approximately day 19

    The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.

  4. Number of Embryos Transferred at Three Stages of Development Before Implantation

    Time frame: approximately day 24

    The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.

    Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape.

  5. Number of Embryos Frozen

    Time frame: approximately day 24

    The number of embryos that were not transferred but instead were frozen for future use.

  6. Percentage of Participants With Biochemical Pregnancy at Approximately Day 38

    Time frame: approximately day 38 (Day 14 post embryo transfer)

    Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.

  7. Percentage of Participants With Clinical Pregnancy at Week 7

    Time frame: approximately Day 52

    Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.

  8. Percentage of Participants With Ongoing Pregnancy at Week 9

    Time frame: approximately Day 65

    Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.

  9. Estradiol Levels at Day 6

    Time frame: Day 6

    Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.

  10. Human Chorionic Gonadotropin (hCG) Levels at Day 6

    Time frame: Day 6

    Blood tests were sent to a central laboratory to obtain hCG levels.

  11. Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration

    Time frame: approximately day 16

    Blood tests were sent to a central laboratory to obtain progesterone levels.

  12. Number of Live Births Resulting From the In Vitro Fertilization Process

    Time frame: Approximately 10 months

    Number of live births resulting from the IVF process

  13. Participants With Treatment Emergent Adverse Events

    Time frame: Week 1 to week12

    Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:

    mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.

    Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 10, 2008
Registry last updated
Jan 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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