NCT00702351

A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(P05788)

A Phase II, Uncontrolled Pilot Trial to Evaluate That a Single Dose of 100 μg or 150 μg Org 36286 (Corifollitropin Alfa) is Able to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI Using a Long Protocol of GnRH Agonist (Study 38833)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.

Detailed description

In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH agonist which is known to provide profound suppression of endogenous LH and FSH. It was evaluated whether these down-regulated subjects show an appropriate ovarian response to 100 μg or 150 μg Org 36286 during the first week of stimulation. To evaluate this, follicular growth was measured by USS, and serum inhibin-B and E2 levels were assessed.

Conditions

• In Vitro Fertilization

Interventions

Type	Name	Description
DRUG	Org 36286 (corifollitropin alfa)	A single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing \>= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing \<= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group).

Timeline

• Start date: 2005-12-09
• Primary completion: 2007-03-26
• Completion: 2007-07-11
• First posted: 2008-06-20
• Last updated: 2022-02-02