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Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)

NCT01146418 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2024-06-20

Study results available
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Summary

The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Conditions

Interventions

BIOLOGICAL

Corifollitropin alfa

Single injection of 150 μg corifollitropin alfa administered under protocol P06029

BIOLOGICAL

recFSH (follitropin beta)

Daily recFSH 300 IU administered under protocol P06029.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-02
Primary Completion
2013-07-24
Completion
2014-04-29

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Diseases

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 NCT01146418 on ClinicalTrials.gov