CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
GONAL f® prefilled pen +1 moredrug
Likely dose
GONAL f® prefilled pen 112.5 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/NCT00829244
NCT00829244Phase 4Completed
CompareCT.gov

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)

Merck KGaA, Darmstadt, Germany·interventional·Posted Jan 26, 2009·Updated Feb 13, 2014

In Brief

A Phase 4 clinical trial evaluating GONAL f® prefilled pen for Infertility. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 26, 2009
Enrollment StartAug 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.4 years ago

Interventions

GONAL f® prefilled pendrug

GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only

GONAL f® prefilled pendrug

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.