NCT00249834

Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Gonal-f	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.
DRUG	Recombinant human chorionic gonadotrophin (r-hCG)	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.

Timeline

• Start date: 2004-09-22
• Primary completion: 2006-01-16
• Completion: 2006-01-16
• First posted: 2005-11-07
• Last updated: 2018-03-30
• Results posted: 2018-03-30

Locations

1 site across 1 country: France