STUDY QUESTION What are the current national medically assisted reproduction (MAR) data collection systems across EU Member States, and how can these countries contribute to a unique, cycle-by-cycle registry for the European Monitoring of Medically Assisted Reproduction (EuMAR) project? SUMMARY ANSWER The study identified significant variation in MAR data collection practices across Member States, with differences in data types, collection methods, and reporting requirements; the EuMAR project emerges as an opportunity to enhance data standardization and improve MAR data collection in the EU. WHAT IS KNOWN ALREADY There is a need for new approaches in MAR data collection that include long-term and cross border follow-up. The EuMAR project intends to establish a unified, cycle-by-cycle registry of data on MAR treatments in EU countries, from which accurate cumulative outcomes can be calculated. STUDY DESIGN, SIZE, DURATION This cross-sectional study involved a survey and interviews with stakeholders from 26 EU Member States conducted in 2023 over a period of seven months. PARTICIPANTS/MATERIALS, SETTING, METHODS Representatives from national competent authorities and professional associations involved in MAR data collection in EU countries were invited to complete the survey and interviewed to assess current data flows, information requirements, and their interest in the EuMAR project. MAIN RESULTS AND THE ROLE OF CHANCE Half of the participating countries reported having a national MAR registry with cycle-by-cycle data (n = 13), while 31% reported having a national registry with aggregated data (n = 8) and 19% reported having no national registry (n = 5). Of the countries with a national cycle-by-cycle registry, eight countries collect identifiable data, five countries collect pseudonymized data, and one country collects fully anonymized data. Informed consent is required in 10 countries. The main advantages that participants expected from a European registry like EuMAR were the possibility of obtaining national statistics in the absence of a national registry and improving the calculation of cumulative outcomes. LIMITATIONS, REASONS FOR CAUTION The results of the study are based on self-reported data, which may be subject to bias, however, the validity of the collected information was verified with different means, including follow-up calls for clarifications and sharing final transcript reports. The feasibility of the proposed data flow models will be tested in a pilot study. WIDER IMPLICATIONS OF THE FINDINGS Despite the heterogeneity of data collection practices across EU countries, the results show that stakeholders have high expectations of the benefits that the EuMAR registry can bring, namely the improvement of data consistency, cross-border comparability, and cumulative live birth rates, leading to better information for patients, health care providers and policy makers. STUDY FUNDING/COMPETING INTEREST(S) The EuMAR project was co-founded by ESHRE and the European Commission (101079865—EuMAR–EU4H-2021-PJ2). No competing interests were declared. TRIAL REGISTRATION NUMBER N/A.

中文翻译：

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EuMAR 利益相关者参与：欧盟国家医学辅助生殖 （MAR） 数据收集实践分析


研究问题 欧盟成员国目前的国家医学辅助生殖 （MAR） 数据收集系统是什么，这些国家如何为欧洲医学辅助生殖监测 （EuMAR） 项目的独特逐周期登记做出贡献？简要答案 该研究发现，会员国的 MAR 数据收集做法存在显著差异，数据类型、收集方法和报告要求存在差异;EuMAR 项目是加强欧盟数据标准化和改善 MAR 数据收集的机会。已知的 MAR 数据收集需要新的方法，包括长期和跨境随访。EuMAR 项目旨在建立一个统一的、逐周期的欧盟国家 MAR 治疗数据登记处，从中可以计算出准确的累积结果。研究设计、规模、持续时间 这项横断面研究涉及 2023 年对来自 26 个欧盟成员国的利益相关者进行的调查和访谈，为期 7 个月。参与者/材料、设置、方法 来自欧盟国家参与 MAR 数据收集的国家主管当局和专业协会的代表被邀请完成调查并接受采访，以评估当前的数据流、信息要求以及他们对 EuMAR 项目的兴趣。主要结果和机会的作用 一半的参与国家报告了带有逐周期数据的国家 MAR 登记处 （n = 13），而 31% 的国家报告了带有汇总数据的国家登记处 （n = 8），19% 报告没有国家登记处 （n = 5）。 在拥有国家逐周期登记处的国家/地区中，8 个国家/地区收集可识别数据，5 个国家/地区收集假名数据，1 个国家/地区收集完全匿名的数据。10 个国家/地区需要知情同意。参与者期望从像 EuMAR 这样的欧洲登记处获得的主要优势是，在没有国家登记处的情况下获得国家统计数据并改进累积结果的计算。局限性，谨慎的原因 该研究的结果基于自我报告的数据，这些数据可能会受到偏差的影响，但是，所收集信息的有效性是通过不同的方式验证的，包括后续电话澄清和分享最终成绩单报告。拟议的数据流模型的可行性将在试点研究中进行测试。研究结果的更广泛影响 尽管欧盟国家/地区的数据收集做法存在异质性，但结果表明，利益相关者对 EuMAR 登记处可以带来的好处抱有很高的期望，即提高数据一致性、跨境可比性和累积活产率，从而为患者、医疗保健提供者和政策制定者提供更好的信息。研究资金/竞争利益EuMAR 项目由 ESHRE 和欧盟委员会 （101079865—EuMAR–EU4H-2021-PJ2） 共同创立。没有宣布任何竞争利益。试验注册号 N/A。