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

February 1, 2022 updated by: Organon and Co

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Corifollitropin alfa
Single injection of 150 μg corifollitropin alfa administered under protocol P06029
Active Comparator: 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.
Biological: recFSH (follitropin beta)
Daily recFSH 300 IU administered under protocol P06029.
Other Names:
  • Follistim® AQ Cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
Time Frame: 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)
The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2010

Primary Completion (Actual)

July 24, 2013

Study Completion (Actual)

April 29, 2014

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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