Artificial Intelligence in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development (IASEAMP)
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.
Studienübersicht
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Lise Laclautre
- Telefonnummer: 334.73.754.963
- E-Mail: promo_interne_drci@chu-clermontferrand.fr
Studienorte
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Clermont-Ferrand, Frankreich, 63001
- Rekrutierung
- CHU de Clermont-Ferrand
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Kontakt:
- Lise Laclautre
- E-Mail: promo_interne_drci@chu-clermontferrand.fr
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Hauptermittler:
- Laure Chaput, PharmD, PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: Manual procedure
The embryo to be transferred on day 5 is selected by the biologist. |
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Experimental: Artificial intelligence
The embryo to be transferred on day 5 is selected by the artificial intelligence software |
Embryo selection on the 5th day of culture is performed using artificial intelligence |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Comparison of artificial intelligence (AI) Score and Laboratory Embryo Classification
Zeitfenster: 5 days
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Impact of AI on time to obtain a pregnancy
Zeitfenster: up to 6 weeks
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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
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Impact of AI on miscarriage rates
Zeitfenster: up to 6 weeks
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To assess whether artificial intelligence can impact the miscarriage rate among patients treated at the AMP-CECOS clinic. |
up to 6 weeks
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Laure Chaput, PharmD, PhD, ART unit
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RBHP 2023 BRUGNON
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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