At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 710 enrolled
Drug / intervention
Urofollitrophin +1 moredrug
Likely dose
Not stated in 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.
Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.
In Brief
A Phase 4 clinical trial evaluating Urofollitrophin and Follitrophin alpha for Infertility. Completed, enrolled 710 participants across 16 sites in 6 countries.
Detailed Summary
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesBelgium, Italy, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartJan 2014
Primary CompletionJun 2016
Study CompletionAug 2017
TodayJul 2026
First PostedOct 25, 2013
Enrollment StartJan 1, 2014
Primary CompletionJun 1, 2016
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.7 years ago
Interventions
Urofollitrophindrug
Follitrophin alphadrug