Phase 4
Completed N=620
MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
Source: ClinicalTrials.gov NCT02554279 ↗Enrolled (actual)
620
Serious AEs
3.1%
Results posted
Mar 2018
Primary outcomePrimary: Ongoing Pregnancy Rate — 35.5; 30.7 percentage of participants
◆ Published Evidence
Established
50citations · ~17 / year
Highly Purified Human Menopausal Gonadotropin (HP-hMG) Versus Recombinant Follicle-Stimulating Hormone (rFSH) for Controlled Ovarian Stimulation in US Predicted High-Responder Patients: A Cost-Comparison Analysis.
Summary
The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation (COS) following GnRH treatment.
Linked Publications (3)
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Highly Purified Human Menopausal Gonadotropin (HP-hMG) Versus Recombinant Follicle-Stimulating Hormone (rFSH) for Controlled Ovarian Stimulation in US Predicted High-Responder Patients: A Cost-Comparison Analysis.
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Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection.
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Economic evaluation of highly purified human menotropin or recombinant follicle-stimulating hormone for controlled ovarian stimulation in high-responder patients: analysis of the Menopur in Gonadotropin-releasing Hormone Antagonist Single Embryo Transfer-High Responder (MEGASET-HR) trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ongoing Pregnancy Rate |
35.5; 30.7 | — |
| SECONDARY Positive β-human Chorionic Gonadotropin (hCG) Rate |
40.6; 39.5 | — |
| SECONDARY Clinical Pregnancy Rate |
37.1; 33.3 | — |
| SECONDARY Early Pregnancy Loss |
14.3; 23.8 | — |
| SECONDARY Follicular Development as Assessed by TVUS |
99.0; 96.4; 78.4; 69.9; 73.8; 93.2 | — |
| SECONDARY Follicular Development as Assessed by TVUS |
99.0; 96.4; 78.4; 69.9; 73.8; 93.2 | — |
| SECONDARY Number of Oocytes Retrieved |
15.1; 22.2 | — |
| SECONDARY Number of Metaphase II Oocytes |
10.1; 15.9 | — |
| SECONDARY Fertilization Rate |
55.09; 59.07 | — |
| SECONDARY Quality of Embryos |
7.5; 7.4 | — |
| SECONDARY Quality of Embryos |
7.5; 7.4 | — |
| SECONDARY Quality of Blastocysts |
28.3; 30.7; 26.5; 22.5; 45.1; 45.8 | — |
Eligibility Criteria
Inclusion Criteria
- Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days, with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy.
- Subjects must be high responders, defined as subjects who have a serum anti-Müllerian hormone (AMH) ≥5 ng/mL at screening.
- Documented history of infertility (e.g., unable to conceive for at least 12 months or for at least 6 months if receiving donor sperm) with a Day 2 or Day 3 serum FSH level between 1 and 12 IU/L (inclusive), the results of which should be obtained within 6 months prior to randomization.
Exclusion Criteria
- Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
- History of recurrent miscarriage not followed by a live birth (recurrent is defined as two (2) or more consecutive miscarriages).
- 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 cycle cancellations prior to oocytes retrieval due to poor response.
Data sourced from ClinicalTrials.gov (NCT02554279) and the linked publication. 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.