STUDY QUESTION Can a core outcome set to standardize outcome selection, collection, and reporting across future infertility research be developed? SUMMARY ANSWER A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCT) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions, and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin, and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition, and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection, and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Ferility and Sterility, and Human Reproduction, 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. José Knijnenburg reports research sponsorship from Ferring and Theramex. 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 Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. 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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为未来的不孕症研究制定核心成果集：一项国际共识发展研究

研究问题 是否可以制定核心结果集来标准化未来不孕症研究中的结果选择、收集和报告？总结答案 已为随机对照试验 (RCT) 和评估不孕症潜在治疗方法的系统评价开发了一个最小数据集，称为核心结果集。已知情况 复杂的问题，包括在选择结果时没有考虑有生育问题的人的观点、结果定义的变化以及基于统计分析的结果的选择性报告，使不孕症研究的结果难以解释. 研究设计、规模、持续时间 三轮德尔福调查（来自 41 个国家的 372 名参与者）和共识发展研讨会（来自 27 个国家的 30 名参与者）。参与者/材料，设置、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科学方法在公开和透明的过程中聚集在一起。主要结果和机会的作用 核心结果集包括： 经超声确认的可行宫内妊娠（包括单胎、双胎和多胎妊娠）；流产（考虑异位妊娠、流产、死产和终止妊娠）；活产；分娩时的胎龄；出生体重; 新生儿死亡率；和重大的先天性异常。如果适用，应报告妊娠直至活产的时间。局限性、谨慎的原因 我们使用了具有固有局限性的共识制定方法，包括参与者样本的代表性、德尔福调查损耗、和任意的共识阈值。研究结果的更广泛影响 将核心结果集嵌入 RCT 和系统评价应确保核心结果的全面选择、收集和报告。研究资助机构、标准协议项目：介入性试验建议 (SPIRIT) 声明和 80 多种专业期刊，包括 Cochrane 妇科和生育组、生育和不育以及人类生殖，已承诺实施这一核心结果集。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 Gynecology and Fertility 小组的编辑。汉斯·埃弗斯 (Hans Evers) 报道称，他是《人类生殖》杂志的名誉编辑。José Knijnenburg 报道了辉凌和 Theramex 的研究赞助。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》杂志的联合主编和泌尿外科杂志的部分编辑，获得辉凌的研究赞助，并保留了 NexHand 的经济利益。Annika Strandell 报告了 Guerbet 的咨询费。Ernest Ng 报告了默克公司的研究赞助。