Phase 4
N=110
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
Polycystic Ovarian Syndrome · Infertility
Bottom Line
View on ClinicalTrials.gov: NCT00805935 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Jan 2012
Primary outcome: Primary: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 — 1; 0; 1; 0 Participants — p=1.000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Menotropin (Drug); Progesterone vaginal insert (Drug); Follitropin beta (Drug); Progesterone in oil (Drug); leuprolide acetate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 |
1; 0; 1; 0; 24; 27 | 1.000 |
| SECONDARY Number of Follicles Observed at Day 15 |
27.7; 30.5 | — |
| SECONDARY Number of Oocytes Retrieved at Day 18 |
13.0; 15.6 | — |
| SECONDARY Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved |
17.1; 24.8 | — |
| SECONDARY Number of Embryos Transferred at Three Stages of Development Before Implantation |
2.0; 2.0; 0.0; 0.1; 0.8; 1.1 | — |
| SECONDARY Number of Embryos Frozen |
1.9; 1.9 | — |
| SECONDARY Percentage of Participants With Biochemical Pregnancy at Approximately Day 38 |
60.0; 55.6; 60.7; 73.3 | — |
| SECONDARY Percentage of Participants With Clinical Pregnancy at Week 7 |
56.0; 33.3; 46.4; 66.7 | — |
| SECONDARY Percentage of Participants With Ongoing Pregnancy at Week 9 |
48.0; 33.3; 46.4; 63.3 | — |
| SECONDARY Estradiol Levels at Day 6 |
354.6; 268.2; 617.5; 550.5 | — |
| SECONDARY Human Chorionic Gonadotropin (hCG) Levels at Day 6 |
1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration |
1.3; 1.1; 1.7; 1.3 | — |
| SECONDARY Number of Live Births Resulting From the In Vitro Fertilization Process |
— | — |
| SECONDARY Participants With Treatment Emergent Adverse Events |
9; 12; 15; 14; 9; 11 | — |
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
- 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) 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
Data sourced from ClinicalTrials.gov (NCT00805935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.