NCT00829244

CONSORT Randomized Controlled Trial in Assisted Reproductive Technology

A Phase IV Prospective, Multicenter, Randomized, Open-label Trial to Assess the Efficacy and Safety of GONAL f® at a Dose Based on Subject Baseline Characteristics Determined According to the CONSORT Calculator Compared With a Standard Dose of GONAL f® 150 IU Per Day for Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology (ART)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	GONAL f® prefilled pen	GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only
DRUG	GONAL f® prefilled pen	GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-01-26
• Last updated: 2014-02-13
• Results posted: 2012-09-07

Locations

1 site across 1 country: Switzerland