NCT00696878

Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 682 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the non-immunogenicity and safety of corifollitropin alfa in participants undergoing repeated COS cycles for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a multiple dose GnRH antagonist protocol. The trial period per participant will cover 1, 2 or 3 COS treatment cycles and no more than three (in-between two stimulation cycles) Frozen-Thawed Embryo Transfer (FTET) cycles following either or both of the first two treatment cycles. In each stimulation cycle, participants receive a single injection of corifollitropin alfa and one week later, treatment is continued with a daily dose of any FSH-containing preparation up to the day of (rec)hCG administration for final oocyte maturation. Assessment of anti-corifollitropin alfa antibodies and local tolerance after corifollitropin alfa injection are important safety endpoints in this trial.

Conditions

• In Vitro Fertilization

Interventions

Type	Name	Description
DRUG	Corifollitropin alfa	Corifollitropin alfa 150 µg administered as a single subcutaneous dose.
BIOLOGICAL	FSH	FSH administerd subcutaneously at a dose not to exceed 225 IU/day.
BIOLOGICAL	GnRH antagonist	GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.
BIOLOGICAL	(rec)hCG	(rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.
DRUG	Progesterone	Progesterone administered vaginally at a dose of at least 600 mg/day.

Timeline

• Start date: 2006-09-26
• Primary completion: 2009-02-17
• Completion: 2009-05-15
• First posted: 2008-06-13
• Last updated: 2024-06-18
• Results posted: 2015-04-23