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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01146418
First received: June 11, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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 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).


Condition Intervention Phase
Infertility
 Biological: Follow-up procedures after SCH 900962 / Corifollitropin alfa / Org 36286
Biological: Follow-up procedures after RecFSH / follitropin beta
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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)

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Cumulative vital pregnancy rate, ie, the percentage of participants who started COS treatment in P06029 (NCT01144416) and have a vital pregnancy either immediately after embryo transfer in P06029 or after 1 or more FTET cycles in P06031. [ Time Frame: Vital pregnancy will be assessed at least 35 days after embryo transfer (with a timeframe of 35-42 days) in the FTET cycle. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The cumulative live-birth rate [ Time Frame: Live birth will be assessed at the time of delivery, on average at a gestational age of 40 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Follow-up after SCH 900962 single injection in P06029
Study P06031 is a follow-up study for participants who were treated in Study P06029 with corifollitropin alfa (SCH 900962) or recFSH. Participants to be enrolled in this arm of P06031 were administered a single injection of SCH 900962 in Study P06029. No study treatment will be administered in Study P06031.
 Biological: Follow-up procedures after SCH 900962 / Corifollitropin alfa / Org 36286
Study P06031 is a follow-up of participants previously treated with corifollitropin alfa (SCH 900962) or recFSH in Study P06029 (NCT01144416). No SCH 900962 will be administered as part of this follow-up protocol.
Follow-up after daily recFSH in P06029
Study P06031 is a follow-up study for participants who were treated in Study P06029 with corifollitropin alfa (SCH 900962) or recFSH. Participants to be enrolled in this arm of P06031 were administered recFSH in Study P06029. No study treatment will be administered in Study P06031.
 Biological: Follow-up procedures after RecFSH / follitropin beta
Study P06031 is a follow-up of participants previously treated with corifollitropin alfa (SCH 900962) or recFSH in Study P06029 (NCT01144416). No recFSH will be administered as part of this follow-up protocol.
Other Name: Follistim® AQ Cartridge

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146418

  Show 26 Study Locations
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01146418     History of Changes
Other Study ID Numbers: P06031
Study First Received: June 11, 2010
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Reproductive Techniques, Assisted
Follicle Stimulating Hormone, Human
Fertilization In Vitro

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013