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AutoIVF2024 : Sofertility Standard for Autonomous IVF

Taxonomy and Definitions for Terms Related to Autonomous In Vitro Fertilization (IVF) Systems

This document describes autonomous IVF systems that perform part or all of the IVF process on a sustained basis. It provides a taxonomy with detailed definitions for six levels of automation in IVF, ranging from no automation (Level 0) to full automation (Level 5). The taxonomy is designed to provide a consistent and coherent framework for understanding the capabilities and roles of various actors involved in the IVF process, which include the human embryologist, the IVF automation system, and other supporting systems and components.

Levels of Automation in Autonomous IVF

  • Level 0: No Automation
    • Definition: No automated systems are involved in the IVF process. All tasks, including ovarian stimulation, egg retrieval, sperm preparation, fertilization, embryo culture, and selection, are performed manually by human embryologists and clinicians.
    • Human Role: The human embryologist is responsible for performing all aspects of the IVF process.
    • System Role: No role; all processes are manual.
  • Level 1: Assisted IVF
    • Definition: Automation assists in specific tasks, such as data analysis or environment control (e.g., temperature and pH of culture media), but the final decisions are made by human embryologists.
    • Human Role: The embryologist performs all critical tasks but utilizes automated systems for support in data analysis, monitoring, or simple tasks.
    • System Role: Provides assistance in data collection, monitoring, and analysis but does not make critical decisions or perform complex tasks.
  • Level 2: Partial Automation
    • Definition: The system can autonomously perform certain tasks, such as continuous monitoring of embryo development or automated environmental adjustments, while the embryologist supervises and intervenes as necessary.
    • Human Role: The embryologist supervises the process, intervening when needed and making critical decisions such as embryo selection and transfer.
    • System Role: Performs specific tasks autonomously, such as maintaining optimal culture conditions or conducting preliminary assessments of embryo viability, but requires human oversight.
  • Level 3: Conditional Automation
    • Definition: The system can perform the majority of the IVF tasks autonomously under certain conditions, including egg retrieval, fertilization, and early embryo development assessment. The embryologist is on standby to take over if the system encounters conditions beyond its capabilities.
    • Human Role: The embryologist is available to intervene in non-standard situations and for final decision-making in complex cases.
    • System Role: Executes routine IVF procedures autonomously within predefined scenarios, but requests human intervention when conditions exceed its operational domain.
  • Level 4: High Automation
    • Definition: The system manages all aspects of the IVF process autonomously within specific operational conditions. Human intervention is required only in exceptional circumstances.
    • Human Role: The embryologist monitors the overall process but is not required to intervene in standard scenarios.
    • System Role: Manages all critical tasks, including egg retrieval, fertilization, embryo culture, selection, and potentially genetic screening, within defined operational limits.
  • Level 5: Full Automation
    • Definition: The system performs the entire IVF process autonomously in all conditions. The system is capable of handling all scenarios and conditions that could occur during the IVF process without human intervention.
    • Human Role: No role required; the system operates independently.
    • System Role: Fully autonomous, managing all aspects of the IVF process, from initial consultation to embryo transfer, without any human input.

Supporting Terms and Definitions

  • Autonomous IVF System (AIS): An automated system capable of performing part or all of the IVF process autonomously, depending on its level of automation.
  • Human Embryologist: A trained professional who, depending on the level of automation, may perform, supervise, or monitor the IVF process, intervening when necessary.
  • Operational Design Domain (ODD): The specific conditions or scenarios under which the autonomous IVF system is designed to function. This includes parameters such as the types of patients, procedural complexity, and environmental conditions.
  • Embryo Viability Assessment: The process of evaluating embryos based on morphological, genetic, or other criteria to determine their suitability for transfer or freezing.
  • Fallback Responsibility: The role of the human embryologist or the system to take over or adjust the process if the automated system encounters a situation beyond its capabilities or experiences a failure.
  • Data Analytics in IVF: The use of AI and machine learning to analyze patient data, embryo development, and other factors to assist in decision-making during the IVF process.

Actors in Autonomous IVF

  • Human Embryologist: Depending on the level of automation, the embryologist may perform, supervise, or monitor the IVF process. Their role diminishes as the level of automation increases, shifting from active control to monitoring and eventual redundancy at Level 5.
  • Autonomous IVF System: The system that automates various aspects of the IVF process. Its role increases with each level of automation, eventually taking over all tasks at Level 5.
  • Supporting Systems and Components: Other systems involved in the IVF process that support but do not directly contribute to the automation of the IVF tasks. These might include electronic health records (EHR), environmental control systems, and diagnostic tools.

Application of the Taxonomy

This taxonomy applies to the autonomous IVF features that are engaged during any given instance of the IVF process. While a clinic may be equipped with an autonomous IVF system capable of multiple levels of automation, the level of automation in any given instance is determined by the features that are engaged and the role of the human embryologist in that instance.

Exclusions

  • Momentary Assistance Systems: Systems that provide momentary support, such as alerts or warnings, are excluded from this taxonomy because they do not automate the IVF process on a sustained basis.
  • Active Safety Systems: Systems that provide real-time adjustments or interventions during hazardous situations but do not perform sustained IVF tasks are also excluded.

This document provides a framework for understanding and classifying the various levels of automation in IVF, ensuring a consistent and coherent approach to discussing and implementing autonomous IVF systems.