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

Organon

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Biological: Corifollitropin alfa; Biological: recFSH (follitropin beta)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01146418

P06031

Details and patient eligibility

About

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).

Enrollment: 307 patients

Sex: Female

Ages: 35 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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307 participants in 2 patient groups

Corifollitropin alfa 150 μg

Experimental group

Description:

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.

Treatment:

Biological: Corifollitropin alfa

recFSH 300 IU

Active Comparator group

Description:

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.

Treatment:

Biological: recFSH (follitropin beta)