NCT00702546·Not applicable·OBSERVATIONAL

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

Ganirelix Other Completed

Status

Completed

Phase

Not applicable

Enrollment

102

Locations

Results

Posted

Publications

Study summary

What the protocol is testing.

Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.

Full detailed description

This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

First posted
Jun 20, 2008
Study start
Dec 2006
Primary completion
Dec 2008
Study completion
Dec 2008
Results posted
May 5, 2015
Registry updated
Feb 3, 2022

Outcomes

What the study measures.

Primary outcomes

Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)

Time frame · Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711

Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.