A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,509

Participants

Timeline

Start Date

June 27, 2006

Primary Completion Date

November 19, 2007

Study Completion Date

January 15, 2008

Conditions
In Vitro Fertilization
Interventions
DRUG

Corifollitropin alfa

On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.

BIOLOGICAL

RecFSH / Follitropin beta (Days 1 to 7)

Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

DRUG

Placebo Corifollitropin alfa

Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.

DRUG

Placebo RecFSH / follitropin beta

Identical ready-for-use solution, but without the active ingedient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

BIOLOGICAL

RecFSH / Follitropin beta (Days 8 to hCG)

From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.

DRUG

Ganirelix

On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG

BIOLOGICAL

hCG

When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP

BIOLOGICAL

Progesterone

On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00696800 - A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787) | Biotech Hunter | Biotech Hunter