Artificial Intelligence in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development (IASEAMP)

September 21, 2026 updated by: University Hospital, Clermont-Ferrand

Evaluation of the Use of Artificial Intelligence (AiVF) in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development

Embryo selection is one of the major challenges in Assisted Reproductive Technology (ART) in order to continuously improve clinical pregnancy rates. Morphological evaluation of embryos is the standard method used to assess embryo quality and to select the embryo to be transferred. However, this observational method has limitations: it can be subjective and may lead to inter- and intra-observer variability. To increase pregnancy rates, the transfer of two embryos may be proposed, which can result in high-risk multiple pregnancies. Despite the introduction of time-lapse systems and embryo selection algorithms aimed at increasing live birth rates, outcomes in ART remain suboptimal and can still be improved.

The use of artificial intelligence (AI) is expanding in the medical field and is increasingly being applied in ART laboratories to optimize outcomes while avoiding multiple pregnancies. EMA™ is a secure artificial intelligence software platform developed by the company AiVF. The use of this software could allow a standardized and reproducible evaluation of embryo development up to the fifth day of embryonic culture. Through the application of an algorithm, the software may enable the selection of the embryo with the highest potential for achieving pregnancy.

The primary objective of this study is to evaluate the use of the EMA™ artificial intelligence system in embryo selection for embryos cultured up to day 5, in comparison with the morphokinetic criteria currently used in the laboratory for the first fresh transfer of a day-5 embryo.

The secondary objectives are to assess whether artificial intelligence (1) reduces the time to achieve pregnancy (defined as pregnancy achieved or not after the first transfer of a day-5 embryo) and (2) affects the miscarriage rate among patients treated in the ART CECOS unit. A medico-economic analysis will be conducted to evaluate the number of new patients undergoing an additional treatment attempt and to determine whether there is a correlated reduction in time to pregnancy by assessing the number of pregnancies achieved after the first transfer in patients already under treatment. A cost-effectiveness analysis will also be performed, comparing the cost-effectiveness ratios between the two study arms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

550

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 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • First attempt at assisted reproductive technology (ART) treatment using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
  • Treatment for primary infertility of idiopathic or male origin, for single women or female couples
  • Use of fresh sperm from the partner or frozen donor sperm
  • Embryo culture up to the 105th hour of development (the time at which the score is assigned when selecting the embryo to be transferred to the uterus on the 5th day of development (D5))
  • First transfer of a fresh embryo on the 5th day of culture
  • Known Implantation Data (KID) (= clinical pregnancy confirmed by the presence of a heartbeat at 6 weeks via ultrasound)

Exclusion Criteria:

  • Use of frozen sperm from the spouse
  • No oocytes retrieved during oocyte retrieval
  • No blastocysts obtained on the 5th day of development
  • Embryo culture with transfer on the 2nd or 3rd day of development

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Manual procedure

The embryo to be transferred on day 5 is selected by the biologist.
Experimental: Artificial intelligence

The embryo to be transferred on day 5 is selected by the artificial intelligence software
Device: EMA

Embryo selection on the 5th day of culture is performed using artificial intelligence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of artificial intelligence (AI) Score and Laboratory Embryo Classification
Time Frame: 5 days

To evaluate the use of EMA artificial intelligence in embryo selection for embryos cultured through day 5, in comparison with the morphokinetic criteria (gardner classification) used in the laboratory for the first fresh transfer of an embryo cultured through day 5 of development.

Gardner classification : The three blastocyst parameters will be assessed independently: the degree of blastocyst expansion, the quality of the inner cell mass, and the quality of the trophectoderm. These three parameters will then be pooled to generate an overall blastocyst classification.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of AI on time to obtain a pregnancy
Time Frame: up to 6 weeks

To assess whether artificial intelligence can reduce the time to clinical pregnancy (whether or not pregnancy is achieved after the first embryo transfer on the 5th day of culture).
up to 6 weeks
Impact of AI on miscarriage rates
Time Frame: up to 6 weeks

To assess whether artificial intelligence can impact the miscarriage rate among patients treated at the AMP-CECOS clinic.
up to 6 weeks

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Laure Chaput, PharmD, PhD, ART unit

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)

November 4, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 28, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2023 BRUGNON

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.

Subscribe