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CompletedNCT01146418

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

Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
307 (actual)
Sponsor
Organon and Co · Industry
Sex
Female
Age
35 Years – 42 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
BIOLOGICALCorifollitropin alfaSingle injection of 150 μg corifollitropin alfa administered under protocol P06029
BIOLOGICALrecFSH (follitropin beta)Daily recFSH 300 IU administered under protocol P06029.

Timeline

Start date
2010-06-02
Primary completion
2013-07-24
Completion
2014-04-29
First posted
2010-06-17
Last updated
2024-06-20
Results posted
2016-02-03

Source: ClinicalTrials.gov record NCT01146418. Inclusion in this directory is not an endorsement.

Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031) (NCT01146418) · Clinical Trials Directory