Reproductive Techniques, AssistedEBAINCT07383480
Retrospective Evaluation Blastocyst Development by Artificial Intelligency
An observational study of Reproductive Techniques, Assisted and Artificial Intelligence, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Reproductive Techniques, Assisted, Artificial Intelligence, Embryo Transfer
- How many people
- 333 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Couples, single women, or female couples undergoing assisted reproductive technology (ART) with IVF/ICSI techniques followed by blastocyst transfer.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- Artificial intelligence, Embryo selection, IVF outcome, Time-lapse monitoring
- Medical subject headings
- Helping Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of artificial intelligence (AI) Score and Laboratory Embryo Classification
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.
Measured: 01/01/2022-31/12/2023
Secondary outcomes (2)
To determine the association between EMA Score and implantation and live birth rates
To analyze the correlation between EMA scores and these key reproductive outcomes (implatation and live birth rate)
Measured: 01/01/2022-31/12/2023
To evaluate the optimal EMA score threshold for maximizing live birth rates
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.
Measured: 01/01/2022-31/12/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Jan 2022
- Primary completion1 Dec 2023
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive Techniques, AssistedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Brugnon, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383480
- Sponsor's protocol ID
- 2023_BRUGNON_retrospectiveEBAI
- Acronym
- EBAI
- Status last verified
- May 2025
- First submitted
- 26 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Embryo Selection With AiVF: A Major Advancement in ART - A Retrospective Study
- ClinicalTrials.gov ID
- NCT07383480
- Acronym / sponsor ID
- EBAI / 2023_BRUGNON_retrospectiveEBAI
- Keywords
- Artificial intelligence, Embryo selection, IVF outcome, Time-lapse monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Couples, single women, or female couples undergoing assisted reproductive technology (ART) with IVF/ICSI techniques followed by blastocyst transfer.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
To determine the association between EMA Score and implantation and live birth rates
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Brugnon principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Techniques, Assisted and Artificial Intelligence, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of artificial intelligence (AI) Score and Laboratory Embryo Classification (time frame: 01/01/2022-31/12/2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.