Phase 4
Completed N=165
MENOPUR® Versus FOLLISTIM®
Source: ClinicalTrials.gov NCT00802360 ↗Enrolled (actual)
165
Serious AEs
1.2%
Results posted
Aug 2011
Primary outcomePrimary: Percentage of Participants With Ongoing Pregnancy at Week 8 — 45.2; 45.2; 42.9; 48.7 percentage of participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Ongoing Pregnancy at Week 8 |
45.2; 45.2; 42.9; 48.7 | — |
| SECONDARY Number of Follicles Observed at Day 15 |
15.6; 16.2 | — |
| SECONDARY Number of Oocytes Retrieved at Day 18 |
11.5; 13.8 | — |
| SECONDARY Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved |
0.3; 0.3 | — |
| SECONDARY Number of Embryos Transferred at Three Stages of Development |
2.1; 2.4; 0.0; 0.1; 0.9; 0.9 | — |
| SECONDARY Number of Embryos Frozen at Day 24 |
1.9; 1.6 | — |
| SECONDARY Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle |
0; 1; 1; 2 | — |
| SECONDARY Participants With Biochemical Pregnancy at Day 38 |
21; 20; 22; 23 | — |
| SECONDARY Participants With Clinical Pregnancy at Week 7 |
19; 19; 18; 20 | — |
| SECONDARY Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS) |
20; 18; 18; 21; 20; 18 | — |
| SECONDARY Number of Live Births |
— | — |
Eligibility Criteria
Inclusion Criteria
- Pre-menopausal females between the ages of 18 and 42 years
- Body mass index (BMI) of 18-34
- Early follicular phase (day 2-4) 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., 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
- 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.
- History of recurrent pregnancy loss (>2).
- 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])
Data sourced from ClinicalTrials.gov (NCT00802360). 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. Informational only — not medical advice.