Retrospective Evaluation Blastocyst Development by Artificial Intelligency (EBAI)

February 4, 2026 updated by: University Hospital, Clermont-Ferrand

Enhancing Embryo Selection With AiVF: A Major Advancement in ART - A Retrospective Study

In assisted reproductive technology (ART), selecting the most viable embryos from a large number of fertilized eggs is crucial. While techniques like morphological assessment, time-lapse monitoring systems, and pre-implantation genetic testing have improved the process, implantation success rates remain limited. The introduction of artificial intelligence in embryo evaluation, such as automated systems like EMA by AIVFTM, provides a promising alternative to enhance the accuracy and effectiveness of embryo selection. This study aims to assess the performance of the EMA system compared to traditional methods by examining its ability to rank embryos based on their potential for successful implantation, with the goal of increasing the chances of a successful pregnancy. This is the first clinical evaluation of this platform in France, offering new opportunities to improve decision-making in in-vitro fertilization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

This monocentric study analyzes 420 ART cycles from the Clermont-Ferrand University Hospital, conducted between January 2022 and December 2023. It includes IVF/ICSI cycles with embryos cultured in a Time-Lapse Incubator (Geri) and both fresh and frozen blastocyst transfers. A total of 1211 embryos were analyzed, with 619 used to train algorithms for predicting reproductive outcomes. This included 551 single and 34 double embryo transfer cycles, divided into 274 fresh and 345 frozen blastocyst transfers. For all blastocyst-stage embryos, the Geri score, Gardner classification, and EMA score based on time-lapse video were recorded for statistical analysis and evaluation of reproductive outcome predictions

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.
Observational

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.
333

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

  • France
      • Clermont-Ferrand, France
        • Chu de Clermont-Ferrand

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Couples, single women, or female couples undergoing assisted reproductive technology (ART) with IVF/ICSI techniques followed by blastocyst transfer.

Description

Inclusion Criteria:

  • IVF or ICSI treatment between January 2022 and December 2023
  • Fresh or frozen sperm from the partner or a donor
  • Embryo culture up to the 105th hour
  • Fresh or frozen embryo transfer on Day 5
  • Known implantation data (clinical pregnancy assessed by the presence of cardiac activity at 6 weeks via ultrasound)

Exclusion Criteria:

  • Epididymal or testicular sperm
  • Embryo culture with transfer on Day 2 or Day 3
  • ICSI with oocyte donation or the use of thawed oocytes
  • Transfer of two embryos resulting in a singleton pregnancy
  • No blastocyst obtained on Day 5

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

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
Comparison of artificial intelligence (AI) Score and Laboratory Embryo Classification
Time Frame: 01/01/2022-31/12/2023
The study aims to compare the EMA score assigned by the EMA platform (AiVFTM), an artificial intelligence-based tool, with the manual embryo classification performed by embryologists in the laboratory. This manual classification includes morphological assessment using the Gardner grading system and morphokinetic evaluation through the GERI score. The goal is to determine the level of concordance between the AI-generated scores and traditional embryologist assessments, and to evaluate the relationship and possible variability between the EMA score and the manual scoring methods.
01/01/2022-31/12/2023

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
To determine the association between EMA Score and implantation and live birth rates
Time Frame: 01/01/2022-31/12/2023
To analyze the correlation between EMA scores and these key reproductive outcomes (implatation and live birth rate)
01/01/2022-31/12/2023
To evaluate the optimal EMA score threshold for maximizing live birth rates
Time Frame: 01/01/2022-31/12/2023
To identify the optimal EMA score threshold that is most strongly associated with the highest live brith rates in assisted reproductive technology (ART). By analyzing the relationship between different EMA score levels and live birth outcomes, the study seeks to establish a predictive threshold that could guide embryo selection, thereby improving the likelihood of successful live birth following embryo transfer.
01/01/2022-31/12/2023

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, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Florence Brugnon, University Hospital, Clermont-Ferrand

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.
January 1, 2022

Primary Completion (Actual)

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.
December 1, 2023

Study Completion (Actual)

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.
April 30, 2025

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).
January 26, 2026

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.
January 26, 2026

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.
February 3, 2026

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.
February 6, 2026

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.
February 4, 2026

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.
May 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.
  • 2023_BRUGNON_retrospectiveEBAI

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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