InfertilityIASEAMPNCT07844083
Artificial Intelligence in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development
A study testing EMA in people with Infertility, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- EMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2024to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63001
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Laure Chaput, PharmD, PhD
About this study
Official title: 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.
Read more
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.
- Conditions
- Infertility
- Being tested
- EMA
- Keywords
- Artificial intelligence, Embryo selection, IVF outcome, Time-lapse monitoring
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMADevice
Embryo selection on the 5th day of culture is performed using artificial intelligence
| Study group | Role | What they receive |
|---|---|---|
| Manual procedure | No intervention | The embryo to be transferred on day 5 is selected by the biologist. |
| Artificial intelligence | Experimental | The embryo to be transferred on day 5 is selected by the artificial intelligence software Receives: Device: EMA |
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
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.
Measured: 5 days
Secondary outcomes (2)
Impact of AI on time to obtain a pregnancy
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).
Measured: up to 6 weeks
Impact of AI on miscarriage rates
To assess whether artificial intelligence can impact the miscarriage rate among patients treated at the AMP-CECOS clinic.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start4 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Chaput, PharmD, PhD, Principal investigator, ART unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844083
- Sponsor's protocol ID
- RBHP 2023 BRUGNON
- Acronym
- IASEAMP
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Artificial Intelligence (AiVF) in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development
- ClinicalTrials.gov ID
- NCT07844083
- Acronym / sponsor ID
- IASEAMP / RBHP 2023 BRUGNON
- Conditions
- Infertility
- Keywords
- Artificial intelligence, Embryo selection, IVF outcome, Time-lapse monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 28 Sep 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual procedure | No intervention | –The embryo to be transferred on day 5 is selected by the biologist. |
| Artificial intelligence | Experimental | Device: EMAThe embryo to be transferred on day 5 is selected by the artificial intelligence software |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMAEmbryo selection on the 5th day of culture is performed using artificial intelligence | Device | Artificial intelligence |
Primary outcome
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.
2 secondary outcomes
Impact of AI on time to obtain a pregnancy
Time frame: up to 6 weeks
Impact of AI on miscarriage rates
Time frame: up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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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.
Laure Chaput, PharmD, PhD principal investigator
ART unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMA in people with Infertility, 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. 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: 5 days). 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 28 Sep 2026.