EmbryoTrust: A Blockchain-Based Framework for Trustworthy, Secure, and Ethical In Vitro Fertilization Data Management and Fertility Preservation

Abstract

Assisted Reproductive Technology (ART), particularly In Vitro Fertilization (IVF), generates highly sensitive medical data classified as Protected Health Information (PHI) under international privacy and data protection laws. Ensuring the secure, transparent, and ethically governed management of this data is both essential and legally mandated. However, conventional Electronic Medical Record (EMR) systems often present significant challenges, including data-integrity risks, unauthorized access, and limited patient control—issues that become especially critical in contexts such as fertility preservation for cancer patients. EmbryoTrust introduces a blockchain-based framework designed to ensure the confidentiality, integrity, and availability of IVF-related information through a private, permissioned network integrated with role-based access control (RBAC). Smart contracts, implemented in Solidity on the Ethereum platform, verify spousal identities and enforce data immutability in compliance with religious legislation and ethical regulations. Off-chain data are stored in MongoDB for scalable, privacy-preserving management, while on-chain summaries provide tamper-evident traceability and verifiable auditability. The system was deployed and validated on the Ethereum Holešky testnet using Solidity 0.8.21 and Node.js 18.17, achieving an average transaction-confirmation time of 2.8 s, 99.9% uptime and a 95% user-satisfaction rate. Functional, integration, and usability testing confirmed secure and efficient data handling with minimal computational overhead. Comparative analysis demonstrated that the hybrid on-/off-chain architecture reduces latency and gas costs while maintaining automated compliance enforcement. The modular design enables adaptation to other jurisdictions by reconfiguring ethical and regulatory parameters within the smart-contract layer, ensuring flexibility for global deployment. Overall, the EmbryoTrust framework illustrates how blockchain logic can technically enforce medical and ethical rules in real time, providing a reproducible model for secure, culturally compliant, and privacy-preserving digital-health information management. Its alignment with Saudi Vision 2030 and the Wold Health Organization (WHO) Global Strategy on Digital Health 2020–2025 highlights its potential as a scalable solution for next-generation ART information systems.