Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

CompletedOBSERVATIONAL
Enrollment

102

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
In Vitro Fertilization
Interventions
DRUG

corifollitropin alfa

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

BIOLOGICAL

recFSH (follitropin alfa)

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

DRUG

human chorion gonadatropin (hCG)

hCG 5,000 IU or 10,000 IU administered SC 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 alfa)

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

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00702546 - Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711) | Biotech Hunter | Biotech Hunter