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) | Biotech Hunter

Enrollment

397

Participants

Timeline

Start Date

December 28, 2006

Primary Completion Date

July 7, 2007

Study Completion Date

November 15, 2007

Conditions

Infertility

Interventions

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.

All Listed Sponsors

lead

Organon and Co

INDUSTRY