What Embryoselection for What Chance of Success ? EmbryoSelect Study (EmbryoSelect)

December 6, 2023 updated by: University Hospital, Bordeaux

A Randomized Double-blind Trial Evaluating the Live Birth Rate After Transfer of Embryos Cultured in Time Lapse Incubator Compared With Conventional Incubator: Embryoselect

The aim of the research is to evaluate the results of the first in vitro fertilization (IVF) attempt according to the type of embryo culture. From the fertilization to the day 2 transfer, embryos are cultured in standard incubator or in a time lapse technology (TLT). TLT offers an uninterrupted culture environment with a morphokinetic evaluation, whereas culture in standard incubator involves discontinuous morphological embryo evaluation. The principal objective is to compare the live birth rate after the fresh embryo transfer, in a cohort of women less than 39 years-old.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Embryo evaluation and selection is fundamental in clinical IVF in order to obtain a live birth in a shorter delay as possible, but minimizing the risk of multiple pregnancies. TLT was introduced few years ago in clinical practice and allows the continuous follow up of the embryo development. In IVF centers, embryos are preferentially cultured in TL system with undisturbed environmental conditions. This provides information about the development of the embryos in time intervals of 15min and adds kinetic criteria for embryo evaluation and selection. In conventional incubator, the follow up of embryo development consists in 3 static time point observations. Many reviews and observational studies have discussed the value of time-lapse monitoring but it is as yet unclear, however, whether the TLT improves the results of IVF. It has been suggested that the clinical benefits of applying new technologies should be verified and documented by randomized controlled trials. Moreover, the cumulative live birth rate and the delay for conception were rarely reported. The study aims to evaluate the results of the first IVF attempts comparing classical embryo culture in standard incubator and embryo culture and follow up in TLT. The hypothesis is that the undisturbed culture and the selection based on continuous time-lapse images improve the results of the single embryo fresh transfer and increase the cumulative live birth rate. Patients will be randomized the day of the puncture for the type of culture: standard incubation or TLT. The results of the fresh and successive vitrified-warmed embryo transfer will be prospectively collect and patients will be followed until live birth. The attempt will be considered ended after a live birth, if all the frozen embryos are transferred, after 24 months follow up or after surrender.

Study Type

Interventional

Enrollment (Estimated)

500

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 Contact

Study Locations

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 39 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • first IVF/ICSI attempt with fresh transfer,
  • women ≥18 years-old and <39 years-old,
  • signed informed consent

Exclusion Criteria:

  • attempts with donor,
  • comprehension problem,
  • frozen gametes,
  • BMI>35 kg/m2,
  • history of 3 or more miscarriages,
  • uterine pathology,
  • serodiscordant patients

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Embryo culture in time lapse technology (TLT)
In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.
Other: Embryo culture in time lapse technology (TLT)
In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.
Active Comparator: Embryo culture in conventional incubator
For the standard incubation group, the selection for transfer was based on morphological criteria. Embryos will be cultured and selected for fresh transfer.
Other: Embryo culture in conventional incubator
For the standard incubation group, the selection for transfer will be based on morphological criteria. Embryos will be cultured and selected for fresh transfer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: Month 9
Live birth rate per punction after the first single embryo fresh transfer. The live birth will be collected 9 months after the first positive pregnancy test
Month 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative live birth rate
Time Frame: Month 9
Cumulative live birth rate of the attempt (fresh transfer and vitrified-warmed embryo transfers until live birth or use of all vitrified embryos)
Month 9
Clinical pregnancy rate
Time Frame: Week 6
Clinical pregnancy rate (cardiac activity at 6 weeks of amenorrhea) per punction and cumulated
Week 6
Ongoing pregnancy rate
Time Frame: Week 24
Ongoing pregnancy rate (at more than 24 weeks of amenorrhea) per punction and cumulated
Week 24
Delay to obtain a live birth
Time Frame: Month 9
Delay to obtain a live birth (= number of transfers to obtain a live birth)
Month 9

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Collaborators

Programme Hospitalier de Recherche Clinique Inter-Régionale (PHRC-I)

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)

October 1, 2020

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2019/50

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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