CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 166 enrolled
Drug / intervention
Gonal-f +1 moredrug
Likely dose
Recombinant human chorionic gonadotrophin (r-hCG) 250 microgramfrom 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/NCT00249834
NCT00249834Phase 4Completed
CompareCT.gov

A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)

Merck KGaA, Darmstadt, Germany·interventional·Posted Nov 7, 2005·Updated Mar 30, 2018

In Brief

A Phase 4 clinical trial evaluating Gonal-f and Recombinant human chorionic gonadotrophin (r-hCG) for Infertility. Completed, enrolled 166 participants across 1 site.

Detailed Summary

Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2005
Enrollment StartSep 22, 2004
Primary CompletionJan 16, 2006
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.7 years ago

Interventions

Gonal-fdrug

GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.

Recombinant human chorionic gonadotrophin (r-hCG)drug

When at least 1 follicle greater than or equal to (\>=) 18 millimeter (mm) and 2 follicles \>=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.