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

NCT01146418 | Completed Phase 3 Results

• 1 other identifier: P06031
• Study Type: interventional
• Target: 307
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Infertility

Keywords

Reproductive Techniques, Assisted; Follicle Stimulating Hormone, Human; Fertilization In Vitro

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)

  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).

  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)

Secondary Outcomes (1)

• 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)

Study Arms (2)

Corifollitropin alfa 150 μg

EXPERIMENTAL

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.

Biological: Corifollitropin alfa

recFSH 300 IU

ACTIVE COMPARATOR

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.

Biological: recFSH (follitropin beta)

Interventions

Corifollitropin alfa BIOLOGICAL

Single injection of 150 μg corifollitropin alfa administered under protocol P06029

Corifollitropin alfa 150 μg

recFSH (follitropin beta) BIOLOGICAL

Daily recFSH 300 IU administered under protocol P06029.

Also known as: Follistim® AQ Cartridge

recFSH 300 IU

Eligibility Criteria

• Age: 35 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Boostanfar R, Gates D, Guan Y, Gordon K, McCrary Sisk C, Stegmann BJ. Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial. Fertil Steril. 2016 Aug;106(2):300-305.e5. doi: 10.1016/j.fertnstert.2016.03.041. Epub 2016 Apr 16.

  PMID: 27090863 RESULT

MeSH Terms

Conditions

Infertility; Helping Behavior

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 17, 2010
• Study Start: June 2, 2010
• Primary Completion: July 24, 2013
• Study Completion: April 29, 2014
• Last Updated: June 20, 2024
• Results First Posted: February 3, 2016

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share