STUDY QUESTION Can consensus definitions for the core outcome set for infertility be identified in order to recommend a standardized approach to reporting? SUMMARY ANSWER Consensus definitions for individual core outcomes, contextual statements, and a standardized reporting table have been developed. WHAT IS KNOWN ALREADY Different definitions exist for individual core outcomes for infertility. This variation increases the opportunities for researchers to engage with selective outcome reporting, which undermines secondary research and compromises clinical practice guideline development. STUDY DESIGN, SIZE, DURATION Potential definitions were identified by a systematic review of definition development initiatives and clinical practice guidelines and by reviewing Cochrane Gynaecology and Fertility Group guidelines. These definitions were discussed in a face-to-face consensus development meeting, which agreed consensus definitions. A standardized approach to reporting was also developed as part of the process. PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus development methods. MAIN RESULTS AND THE ROLE OF CHANCE Forty-four potential definitions were inventoried across four definition development initiatives, including the Harbin Consensus Conference Workshop Group and International Committee for Monitoring Assisted Reproductive Technologies, 12 clinical practice guidelines, and Cochrane Gynaecology and Fertility Group guidelines. Twenty-seven participants, from 11 countries, contributed to the consensus development meeting. Consensus definitions were successfully developed for all core outcomes. Specific recommendations were made to improve reporting. LIMITATIONS, REASONS FOR CAUTION We used consensus development methods, which have inherent limitations. There was limited representation from low- and middle-income countries. WIDER IMPLICATIONS OF THE FINDINGS A minimum data set should assist researchers in populating protocols, case report forms, and other data collection tools. The generic reporting table should provide clear guidance to researchers and improve the reporting of their results within journal publications and conference presentations. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials statement, and over 80 specialty journals have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S) This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund, and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger reports being the Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and a financial interest in NexHand. Ernest Ng reports research sponsorship from Merck. Annika Strandell reports consultancy fees from Guerbet. Jack Wilkinson reports being a statistical editor for the Cochrane Gynaecology and Fertility group. Andy Vail reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and of the journal Reproduction. His employing institution has received payment from HFEA for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form. TRIAL REGISTRATION NUMBER Core Outcome Measures in Effectiveness Trials Initiative: 1023.

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不孕症核心结果集的标准化定义和报告指南：一项国际共识发展研究

研究问题 是否可以确定不孕症核心结果集的共识定义，以便推荐标准化的报告方法？总结答案 已经制定了个人核心结果、上下文陈述和标准化报告表的共识定义。已知信息 对于不孕症的各个核心结果存在不同的定义。这种变化增加了研究人员参与选择性结果报告的机会，这会破坏二次研究并损害临床实践指南的制定。研究设计、规模、持续时间 通过对定义制定计划和临床实践指南的系统审查以及通过审查 Cochrane 妇科和生育小组指南，确定了潜在的定义。这些定义在面对面的共识制定会议上进行了讨论，会议达成了共识定义。作为该过程的一部分，还制定了一种标准化的报告方法。参与者/材料、环境、方法 医疗保健专业人员、研究人员和有生育问题的人使用正式的共识制定方法在公开透明的过程中聚集在一起。主要结果和机会的作用 在四个定义开发计划中列出了 44 个潜在定义，包括哈尔滨共识会议研讨会组和国际监测辅助生殖技术委员会、12 个临床实践指南以及 Cochrane 妇科和生育组指南。来自 11 个国家的 27 名参与者，促成共识发展会议。为所有核心成果成功制定了共识定义。提出了改进报告的具体建议。限制，谨慎的原因我们使用了共识开发方法，这些方法具有固有的局限性。来自低收入和中等收入国家的代表有限。研究结果的更广泛影响 最小数据集应有助于研究人员填充协议、病例报告表和其他数据收集工具。通用报告表应为研究人员提供明确的指导，并改进他们在期刊出版物和会议报告中的结果报告。研究资助机构，标准协议项目：介入性试验建议声明，80 多种专业期刊已承诺实施这一核心成果集。研究资金/竞争利益 本研究由催化剂基金、新西兰皇家学会、奥克兰医学研究基金以及 Maurice 和 Phyllis Paykel 信托基金资助。Siladitya Bhattacharya 自称是 Human Reproduction Open 的主编和 Cochrane 妇科和生育组的编辑。汉斯·埃弗斯 (Hans Evers) 报道称，他是《人类生殖》杂志的名誉编辑。Richard Legro 报告了 Abbvie、Bayer、Ferring、Fractyl、Insud Pharma 和 Kindex 的咨询费以及 Guerbet 和 Hass Avocado Board 的研究赞助。Ben Mol 报告了 Guerbet、iGenomix、Merck、Merck KGaA 和 ObsEva 的咨询费。克雷格·尼德伯格 (Craig Niederberger) 报告说，他是《生育与不育》杂志的主编和泌尿外科杂志的部分编辑，Ferring 的研究赞助，以及 NexHand 的经济利益。Ernest Ng 报告了默克公司的研究赞助。Annika Strandell 报告了 Guerbet 的咨询费。Jack Wilkinson 是 Cochrane 妇科和生育小组的统计编辑。Andy Vail 报告说，他是 Cochrane Gynecology & Fertility Review Group 和 Reproduction 杂志的统计编辑。他的雇佣机构已收到 HFEA 的报酬，因为他对研究证据的审查提出了建议，以告知他们用于不孕症治疗“附加组件”的“红绿灯”系统。Lan Vuong 报告了辉凌、默克和默克夏普和 Dohme 的咨询和会议费用。其余作者声明没有与所提交作品相关的竞争利益。所有作者均已完成披露表。