CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 749 enrolled
Drug / intervention
Highly purified menotrophin +1 moredrug
Likely dose
Highly purified menotrophin 150 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00884221
NCT00884221Phase 3Completed
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A Randomized, Open-label, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy of MENOPUR Versus Recombinant FSH in Controlled Ovarian Stimulation Following a GnRH Antagonist Protocol and Single Embryo Transfer

Ferring Pharmaceuticals·interventional·Posted Apr 20, 2009·Updated Apr 20, 2012

In Brief

A Phase 3 clinical trial evaluating Highly purified menotrophin and Recombinant FSH for Infertility. Completed, enrolled 749 participants across 25 sites in 7 countries.

Detailed Summary

The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH) antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a single embryo was transferred at the blastocyst stage.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesBelgium, Czechia, Denmark, Poland, Spain, Sweden, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2009
Enrollment StartJul 1, 2009
Primary CompletionJul 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.2 years ago

Interventions

Highly purified menotrophindrug

The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days. NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion.

Recombinant FSHdrug

The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days. NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion.