NCT00702845

To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)

A Phase III, Randomized, Double-blind, Active-controlled, Equivalence Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 100 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily Recombinant FSH (recFSH) as a Reference

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.

Detailed description

This is a randomized, double-blind, active-controlled, equivalence clinical trial investigating the efficacy and safety of a new treatment regimen with Org 36286, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in COS for Assisted Reproductive Technology (ART). For this regimen, patients receive a single injection of Org 36286 and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group patients receive daily injections of recFSH up to the day of triggering final oocyte maturation. Equivalence between the two treatment groups in the number of oocytes retrieved is the primary objective of this trial.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	corifollitropin alfa (Org 36286)	100 µg corifollitropin alfa subcutaneous (SC) injection
DRUG	recFSH (follitropin beta)	150 IU recFSH SC injection
DRUG	gonadatropin releasing hormone (GnRH) antagonist (ganirelix)	GnRH antagonist (ganirelix) administered SC at a dose of 0.25 mg/day
DRUG	human chorion gonadatropin (hCG)	hCG 5,000 IU or 10,000 IU administered SC
BIOLOGICAL	progesterone	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.
DRUG	placebo-recFSH (follitropin alfa)	Placebo-recFSH administered at the equivalent volume of 150 IU/day.
DRUG	placebo-corifollitropin alfa	Single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle.
BIOLOGICAL	open-label recFSH	Open-label recFSH administered up to a maximum dose of 200 IU/day.

Timeline

• Start date: 2006-12-28
• Primary completion: 2007-07-07
• Completion: 2007-11-15
• First posted: 2008-06-20
• Last updated: 2024-06-18
• Results posted: 2015-04-27