Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

CompletedOBSERVATIONAL
Enrollment

113

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

June 30, 2008

Conditions
PregnancyNeonates
Interventions
DRUG

Corifollitropin alfa

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

BIOLOGICAL

recFSH (follitropin beta)

Daily recFSH administered under protocol P05690

DRUG

gonadatropin releasing hormone (GnRH) antagonist ganirelix

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

BIOLOGICAL

human chorion gonadotropin (hCG)

hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690

BIOLOGICAL

progesterone

Under protocol P05690, 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 beta)

Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690

DRUG

placebo-corifollitropin alfa

Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690

BIOLOGICAL

open-label recFSH (follitropin beta)

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00702624 - Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710) | Biotech Hunter | Biotech Hunter