CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 682 enrolled
Drug / intervention
Corifollitropin alfa +4 moredrug
Likely dose
Corifollitropin alfa 150 µgfrom 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/NCT00696878
NCT00696878Phase 3Completed
CompareCT.gov

A Phase III, Uncontrolled Trial to Assess the Non-immunogenicity and Safety of Org 36286 in Patients Undergoing Repeated Controlled Ovarian Stimulation Cycles Using a Multiple Dose GnRH Antagonist Protocol

Organon and Co·interventional·Posted Jun 13, 2008·Updated Jun 18, 2024

In Brief

A Phase 3 clinical trial evaluating Corifollitropin alfa, FSH, and 3 other interventions for In Vitro Fertilization. Completed, enrolled 682 participants.

Detailed Summary

The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIn Vitro Fertilization
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 13, 2008
Enrollment StartSep 26, 2006
Primary CompletionFeb 17, 2009
Study CompletionMay 15, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.1 years ago

Interventions

Corifollitropin alfadrug

Corifollitropin alfa 150 µg administered as a single subcutaneous dose.

FSHbiological

FSH administerd subcutaneously at a dose not to exceed 225 IU/day.

GnRH antagonistbiological

GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.

(rec)hCGbiological

(rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.

Progesteronedrug

Progesterone administered vaginally at a dose of at least 600 mg/day.