P-363 The Croatia Consensus: Establishing International Best Practices for the Validation and Safe Implementation of Artificial Intelligence in Medically Assisted Reproduction (MAR)

Abstract

Abstract Study question What are the key considerations, validation frameworks, and safety guidelines required for the responsible implementation of Artificial Intelligence (AI) systems in MAR clinics? Summary answer The Croatia Consensus establishes internationally agreed-upon best practices for AI validation in MAR, ensuring patient safety, clinical excellence, regulatory compliance, and ethical implementation. What is known already AI applications are increasingly integrated into ART to optimise embryo selection, standardise clinical decision-making, and reduce variability. However, absence of internationally accepted validation frameworks, regulatory guidelines, and ethical oversight poses risks to patient safety and clinical efficacy. Current AI models often lack transparency, generalisation, and robust external validation. Bias in training datasets can lead to inequitable clinical outcomes. The need for structured AI governance in ART is pressing. The Croatia Consensus, formed by global experts (AI Fertility Society), aims to define best practices for AI validation and deployment in MAR clinics. Study design, size, duration A structured Delphi process involving 148 AI and MAR experts was conducted in 2024 to develop international guidelines for AI validation in ART. The consensus methodology included systematic literature reviews, expert panel discussions, and iterative feedback rounds. Topics covered included AI safety, validation protocols, data standardisation, regulatory compliance, and bias mitigation. The final consensus document was reviewed at the AI Fertility Society Meeting and endorsed by multidisciplinary stakeholders, including clinicians, embryologists, ethicists, and AI developers. Participants/materials, setting, methods Consensus guidelines were developed through contributions from embryologists, reproductive specialists, AI researchers, and regulatory experts. The process included a systematic review of AI applications in MAR, gap analysis of existing validation frameworks, and expert recommendations on AI validation strategies. Key aspects included standardised AI reporting (TRIPOD+AI compliance), real-world clinical validation across multiple centres, ethical risk mitigation, and transparent AI decision-making. AI system performance benchmarks were established using clinical outcome measures and patient safety indicators. Main results and the role of chance The Croatia Consensus establishes a comprehensive framework for AI validation in MAR, ensuring patient safety, regulatory compliance, and clinical efficacy. Key recommendations include multi-centre external validation of AI models to ensure generalisation across diverse patient populations, with the TRIPOD+AI framework recommended for transparent reporting. To mitigate bias, AI systems must undergo demographic audits, particularly in embryo selection, to prevent inequitable outcomes. Regulatory compliance with GDPR (EU), FDA (USA), and MHRA (UK) is required before clinical implementation. Transparency is critical; AI models must provide interpretable decisions, including confidence scores, feature importance, and performance metrics. Continuous post-implementation monitoring is essential to detect model drift and ensure patient safety over time. The consensus highlights that unvalidated AI models currently used in MAR clinics may introduce risks to patient outcomes. Implementing the Croatia Consensus framework will help standardise AI validation, mitigate risks, and ensure AI adoption in MAR is both evidence-based and clinically safe. Limitations, reasons for caution The consensus is based on expert opinions and current scientific literature; further empirical studies are required to validate AI best practices. The framework must evolve as AI capabilities and regulatory landscapes develop. Future research should focus on real-world AI deployment outcomes, patient safety, and long-term MAR success rates. Wider implications of the findings This is the first international AI validation framework in MAR. Standardising AI best practices will improve patient safety, optimise clinical outcomes, and enhance trust in AI-assisted fertility treatments. The framework provides a blueprint for MAR clinics, regulatory bodies, and AI developers, ensuring responsible AI integration into reproductive medicine. Trial registration number No

Ähnliche Arbeiten