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

Last updated: June 5, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Infertility

Treatment

Corifollitropin alfa

recFSH (follitropin beta)

Clinical Study ID

NCT01146418
P06031
  • Ages 35-42
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must have provided written informed consent for the trial.

  • Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.

Study Design

Total Participants: 307
Treatment Group(s): 2
Primary Treatment: Corifollitropin alfa
Phase: 3
Study Start date:
June 02, 2010
Estimated Completion Date:
April 29, 2014