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

March 28, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bayonne, France
        • Clinique Belharra
      • Bordeaux, France
        • CHU Bordeaux

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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