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  5. Trial emulation for validating the clinical efficacy of a foundational AI model in embryo selection

Trial emulation for validating the clinical efficacy of a foundational AI model in embryo selection

File(s)
42026141.pdf (2.47 MB)
Permanent Link(s)
https://hdl.handle.net/1813/126886
Collections
Department of Obstetrics and Gynecology
Author
Rajendran, Suraj
Malmsten, Jonas E.
Arnal, Lorena B.
Meseguer, Marcos
Rosenwaks, Zev
Zaninovic, Nikica
Hajirasouliha, Iman
Abstract

AI models for embryo selection often rely on correlational metrics that ignore clinical confounders. We present a target trial emulation framework to approximate causal effects for a foundational AI model, FEMI, for non-invasive embryo assessment using multi-center trial emulation (n = 4674). Propensity score matching established a robust association between FEMI-Ploidy and implantation failure showing an average treatment effect (ATE) of -0.131 (95% CI [-0.196, -0.066]) in the development cohort and -0.157 (95% CI [-0.254, -0.054]) in the external cohort. Comparative efficacy using S-Learner models demonstrated that a high-risk FEMI score carried a significantly stronger individual treatment effect (ITE) penalty on implantation compared to other scoring mechanisms (p < 0.0001). This superiority persisted after adjusting for maternal age, suggesting FEMI captures unique biological features. This causal framework establishes a rigorous standard for AI validation in IVF, providing the necessary pre-clinical justification for prospective randomized controlled trials.

Journal / Series
NPJ digital medicine
Volume & Issue
9(1)
Date Issued
2026-04-23
Publisher
Nature Research
Keywords
WCM Library Coordinated Deposit
Related DOI
https://doi.org/10.1038/s41746-026-02672-9
Previously Published as
Rajendran S, Malmsten JE, Arnal LB, Meseguer M, Rosenwaks Z, Zaninovic N, Hajirasouliha I. Trial emulation for validating the clinical efficacy of a foundational AI model in embryo selection. NPJ digital medicine. 2026;9(1). doi: 10.1038/s41746-026-02672-9. PMID: 42026141.
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International
Rights URI
https://creativecommons.org/licenses/by-nc-nd/4.0/
Type
article

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