Clinical trial

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)

Name

P06031

Description

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).

Trial arms

Trial start

2010-06-02

Estimated PCD

2013-07-24

Trial end

2014-04-29

Status

Completed

Phase

Early phase I

Treatment

Corifollitropin alfa

Single injection of 150 μg corifollitropin alfa administered under protocol P06029

Arms:

Corifollitropin alfa 150 μg

recFSH (follitropin beta)

Daily recFSH 300 IU administered under protocol P06029.

Arms:

recFSH 300 IU

Other names:

Follistim® AQ Cartridge

Size

307

Primary endpoint

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)

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 307, 'type': 'ACTUAL'}}

Updated at

2024-05-22

1 organization

2 products

1 indication

Organization

Product

Indication

Product