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

NCT00702546 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2022-02-03

Study results available
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Summary

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.

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00702546 on ClinicalTrials.gov