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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-02

Study Completion Date

2014-04-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Corifollitropin alfa 150 μg

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.

Group Type EXPERIMENTAL

Corifollitropin alfa

Intervention Type BIOLOGICAL

Single injection of 150 μg corifollitropin alfa administered under protocol P06029

recFSH 300 IU

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.

Group Type ACTIVE_COMPARATOR

recFSH (follitropin beta)

Intervention Type BIOLOGICAL

Daily recFSH 300 IU administered under protocol P06029.

Interventions

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Corifollitropin alfa

Single injection of 150 μg corifollitropin alfa administered under protocol P06029

Intervention Type BIOLOGICAL

recFSH (follitropin beta)

Daily recFSH 300 IU administered under protocol P06029.

Intervention Type BIOLOGICAL

Other Intervention Names

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Follistim® AQ Cartridge

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No