CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 113 enrolled
Drug / intervention
Corifollitropin alfa +7 moredrug
Likely dose
Corifollitropin alfa 100 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/NCT00702624
NCT00702624N/ACompleted
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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of Org 36286 (Corifollitropin Alfa)

Organon and Co·observational·Posted Jun 20, 2008·Updated Feb 3, 2022

In Brief

An observational study evaluating Corifollitropin alfa, recFSH (follitropin beta), and 6 other interventions for Pregnancy and Neonates. Completed, enrolled 113 participants.

Detailed Summary

The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Neonates
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2008
Enrollment StartApr 1, 2007
Primary CompletionApr 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.0 years ago

Interventions

Corifollitropin alfadrug

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

recFSH (follitropin beta)biological

Daily recFSH administered under protocol P05690

gonadatropin releasing hormone (GnRH) antagonist ganirelixdrug

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

human chorion gonadotropin (hCG)biological

hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690

progesteronebiological

Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.

placebo-recFSH (follitropin beta)drug

Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690

placebo-corifollitropin alfadrug

Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690

open-label recFSH (follitropin beta)biological

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690