Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos

March 10, 2022 updated by: Sophie Debrock

Cumulative Pregnancy Rates and Direct Healthcare Cost Analysis of Two Different Strategies: Fresh Cleavage-stage Embryo Transfer (ET) on Day 3 With Vitrification of Supernumerary Embryos on Day 3 Versus Day 5

This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos.

The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. The secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Leuven University Fertility Center

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

18 years to 37 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment
  • who are older than 18 and less than 38 years old
  • who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels

Exclusion Criteria:

  • treatment with donor oocytes or donor embryos
  • patients planned for Pre-implantation Genetic Diagnosis (PGD)
  • Patients with BMI>30
  • patients with endometriosis grade III-IV

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Day 3 vitrification
Day of vitrification of supernumerary embryos is day 3
Procedure: Day of vitrification
Supernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5
ACTIVE_COMPARATOR: Day 5 vitrification
Day of vitrification of supernumerary embryos is day5
Procedure: Day of vitrification
Supernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulative pregnancy rate
Time Frame: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles)
Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost analysis
Time Frame: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
cost analysis of day 3 and day 5 vitrification strategy
Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year

Collaborators and Investigators

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

Sponsor

Sophie Debrock

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)

January 15, 2018

Primary Completion (ACTUAL)

July 31, 2020

Study Completion (ACTUAL)

December 30, 2021

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

December 10, 2019

First Posted (ACTUAL)

December 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S60974

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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