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

Phase 3

Completed

• Conditions: Infertility
• Interventions: Biological: Corifollitropin alfa; Biological: recFSH (follitropin beta)

• Registration Number: NCT01146418
• Lead Sponsor: Organon and Co

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-02
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2013-07-24
• Study Completion: 2014-04-29
• Results First Submitted: 2015-10-01
• Results First Submitted QC: 2016-01-04
• Results First Posted: 2016-02-03
• Status Verified: 2022-02
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 307

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corifollitropin alfa 150 μg	Corifollitropin alfa	Participants in Base Study P06029 received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.
recFSH 300 IU	recFSH (follitropin beta)	Participants in the reference group in Base Study P06029 received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)	Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)	The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)	From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)	The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.