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Top 10 priorities for future infertility research: an international consensus development study
Fertility and Sterility ( IF 6.6 ) Pub Date : 2021-01-01 , DOI: 10.1016/j.fertnstert.2020.11.014
J M N Duffy 1 , G D Adamson 2 , E Benson 3 , S Bhattacharya 4 , S Bhattacharya 4 , M Bofill 5 , K Brian 6 , B Collura 7 , C Curtis 8 , J L H Evers 9 , R G Farquharson 10 , A Fincham 11 , S Franik 12 , L C Giudice 13 , E Glanville 14 , M Hickey 15 , A W Horne 16 , M L Hull 17 , N P Johnson 17 , V Jordan 5 , Y Khalaf 18 , J M L Knijnenburg 19 , R S Legro 20 , S Lensen 15 , J MacKenzie 21 , D Mavrelos 22 , B W Mol 23 , D E Morbeck 24 , H Nagels 25 , E H Y Ng 26 , C Niederberger 27 , A S Otter 28 , L Puscasiu 29 , S Rautakallio-Hokkanen 11 , L Sadler 30 , I Sarris 31 , M Showell 25 , J Stewart 32 , A Strandell 33 , C Strawbridge 34 , A Vail 35 , M van Wely 36 , M Vercoe 25 , N L Vuong 37 , A Y Wang 38 , R Wang 23 , J Wilkinson 35 , K Wong 8 , T Y Wong 14 , C M Farquhar 39 ,
Affiliation  

STUDY QUESTION Can the priorities for future research in infertility be identified? SUMMARY ANSWER The top 10 research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction, and ethics, access, and organization of care for people with fertility problems were identified. WHAT IS KNOWN ALREADY Many fundamental questions regarding the prevention, management, and consequences of infertility remain unanswered. This is a barrier to improving the care received by those people with fertility problems. STUDY DESIGN, SIZE, DURATION Potential research questions were collated from an initial international survey, a systematic review of clinical practice guidelines, and Cochrane systematic reviews. A rationalized list of confirmed research uncertainties was prioritized in an interim international survey. Prioritized research uncertainties were discussed during a consensus development meeting. Using a formal consensus development method, the modified nominal group technique, diverse stakeholders identified the top 10 research priorities for each of the categories male infertility, female and unexplained infertility, medically assisted reproduction, and ethics, access, and organization of care. PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, people with fertility problems, and others (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process using formal consensus methods advocated by the James Lind Alliance. MAIN RESULTS AND THE ROLE OF CHANCE The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions. A rationalized list of 231 confirmed research uncertainties were entered into an interim prioritization survey completed by 317 respondents from 43 countries. The top 10 research priorities for each of the four categories male infertility, female and unexplained infertility (including age-related infertility, ovarian cysts, uterine cavity abnormalities, and tubal factor infertility), medically assisted reproduction (including ovarian stimulation, IUI, and IVF), and ethics, access, and organization of care, were identified during a consensus development meeting involving 41 participants from 11 countries. These research priorities were diverse and seek answers to questions regarding prevention, treatment, and the longer-term impact of infertility. They highlight the importance of pursuing research which has often been overlooked, including addressing the emotional and psychological impact of infertility, improving access to fertility treatment, particularly in lower resource settings, and securing appropriate regulation. Addressing these priorities will require diverse research methodologies, including laboratory-based science, qualitative and quantitative research, and population science. LIMITATIONS, REASONS FOR CAUTION We used consensus development methods, which have inherent limitations, including the representativeness of the participant sample, methodological decisions informed by professional judgement, and arbitrary consensus definitions. WIDER IMPLICATIONS OF THE FINDINGS We anticipate that identified research priorities, developed to specifically highlight the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems, and others, will help research funding organizations and researchers to develop their future research agenda. STUDY FUNDING/ COMPETING INTEREST(S) The study was funded by the Auckland Medical Research Foundation, Catalyst Fund, Royal Society of New Zealand, and Maurice and Phyllis Paykel Trust. Geoffrey Adamson reports research sponsorship from Abbott, personal fees from Abbott and LabCorp, a financial interest in Advanced Reproductive Care, committee membership of the FIGO Committee on Reproductive Medicine, International Committee for Monitoring Assisted Reproductive Technologies, International Federation of Fertility Societies, and World Endometriosis Research Foundation, and research sponsorship of the International Committee for Monitoring Assisted Reproductive Technologies from Abbott and Ferring. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and editor for the Cochrane Gynaecology and Fertility Group. Hans Evers reports being the Editor Emeritus of Human Reproduction. Andrew Horne reports research sponsorship from the Chief Scientist's Office, Ferring, Medical Research Council, National Institute for Health Research, and Wellbeing of Women and consultancy fees from Abbvie, Ferring, Nordic Pharma, and Roche Diagnostics. M. Louise Hull reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. Neil Johnson reports research sponsorship from Abb-Vie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics, and Vifor Pharma. 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. Ernest Ng reports research sponsorship from Merck. 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. Jane Stewart reports being employed by a National Health Service fertility clinic, consultancy fees from Merck for educational events, sponsorship to attend a fertility conference from Ferring, and being a clinical subeditor of Human Fertility. 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 present work. All authors have completed the disclosure form. TRIAL REGISTRATION NUMBER Not applicable.

中文翻译:

未来不育研究的十大优先事项:国际共识发展研究

研究问题 能否确定未来不育症研究的重点?总结性回答 确定了男性不育症、女性不育症和不明原因不孕症、医学辅助生殖以及生育问题患者的伦理、获取和护理组织这四个领域的前 10 项研究重点。已知信息 关于不孕症的预防、管理和后果的许多基本问题仍未得到解答。这是改善那些有生育问题的人接受的护理的障碍。研究设计、规模、持续时间 潜在的研究问题是从最初的国际调查、临床实践指南的系统评价和 Cochrane 系统评价中整理出来的。在一项临时国际调查中,对已确认研究不确定性的合理化列表进行了优先排序。在共识制定会议期间讨论了优先研究的不确定性。使用正式的共识发展方法,修改后的名义群体技术,不同的利益相关者确定了男性不育症、女性和不明原因不育症、医学辅助生殖以及伦理、获取和护理组织等类别的前 10 个研究重点。参与者/材料、环境、方法 医疗保健专业人员、有生育问题的人和其他人(医疗保健资助者、医疗保健提供者、医疗保健监管者、研究资助机构和研究人员)被聚集在一个公开透明的过程中,使用 James 倡导的正式共识方法林德联盟。主要结果和机会的作用 来自 40 个国家的 388 名参与者完成了初步调查,并提交了 423 个潜在的研究问题。十四项临床实践指南和 162 项 Cochrane 系统评价确定了另外 236 个潜在的研究问题。由来自 43 个国家/地区的 317 名受访者完成的中期优先排序调查中输入了一份包含 231 项已确认研究不确定性的合理化清单。男性不育症、女性不育症和不明原因不孕症(包括年龄相关性不育症、卵巢囊肿、宫腔异常和输卵管因素不孕症)、医学辅助生殖(包括卵巢刺激、IUI 和 IVF)四类的前 10 项研究重点), 以及护理的伦理、获取和组织,在一次有来自 11 个国家的 41 名与会者参加的共识发展会议上确定了这一点。这些研究重点是多种多样的,旨在寻找有关预防、治疗和不孕症长期影响的问题的答案。他们强调了进行经常被忽视的研究的重要性,包括解决不孕症的情绪和心理影响,改善获得生育治疗的机会,特别是在资源匮乏的环境中,以及确保适当的监管。解决这些优先事项将需要多种研究方法,包括基于实验室的科学、定性和定量研究以及人口科学。局限性,谨慎的理由 包括参与者样本的代表性、根据专业判断得出的方法论决定以及任意的共识定义。研究结果的更广泛影响 我们预计确定的研究重点,专门强调医疗保健专业人员、有生育问题的人和其他人认为的最紧迫的临床需求,将有助于研究资助组织和研究人员制定他们未来的研究议程。研究资金/竞争利益 该研究由奥克兰医学研究基金会、催化剂基金、新西兰皇家学会以及莫里斯和菲利斯佩克尔信托基金会资助。Geoffrey Adamson 报告了雅培的研究赞助、雅培和 LabCorp 的个人费用、高级生殖护理的经济利益、FIGO 生殖医学委员会、国际辅助生殖技术监测委员会、国际生育学会联合会和世界子宫内膜异位症研究基金会的委员会成员,以及雅培和辉凌国际辅助生殖技术监测委员会的研究赞助。Siladitya Bhattacharya 自述担任 Human Reproduction Open 的主编和 Cochrane 妇科与生育小组的编辑。Hans Evers 自称是 Human Reproduction 的名誉编辑。Andrew Horne 报告了首席科学家办公室、辉凌、医学研究委员会、国家健康研究所和妇女福利研究所的研究赞助以及艾伯维、辉凌、Nordic Pharma 和 Roche Diagnostics 的咨询费。M. Louise Hull 报告了来自 Merck 的资助、来自 Myovant 的资助、来自 Bayer 的资助,在提交的工作和 Embrace Fertility 的所有权之外,这是一家私人生育公司。Neil Johnson 报告了来自 Abb-Vie 和 Myovant Sciences 的研究赞助以及来自 Guerbet、Myovant Sciences、Roche Diagnostics 和 Vifor Pharma 的咨询费。José Knijnenburg 报告了来自 Ferring 和 Theramex 的研究赞助。Richard Legro 报告了来自 Abbvie、Bayer、Ferring、Fractyl、Insud Pharma 和 Kindex 的咨询费以及来自 Guerbet 和 Hass Avocado Board 的研究赞助。Ben Mol 报告了来自 Guerbet、iGenomix、Merck、Merck KGaA 和 ObsEva 的咨询费。Ernest Ng 报告了默克公司的研究赞助。Craig Niederberger 自述担任《生育与不育》杂志的联合主编和《泌尿外科杂志》的版块编辑,Ferring 的研究赞助,并保留对 NexHand 的经济利益。Jane Stewart 报告说她受雇于国家卫生服务生育诊所,从默克公司获得教育活动的咨询费,赞助参加 Ferring 的生育会议,并且是人类生育力的临床副主编。Annika Strandell 报告了 Guerbet 的咨询费。Jack Wilkinson 自述是 Cochrane 妇科和生育小组的统计编辑。Andy Vail 报告说他是 Cochrane 妇科与生育力审查小组和 Reproduction 杂志的统计编辑。他的雇用机构已收到 HFEA 的付款,以表彰他对研究证据审查的建议,以告知他们的不孕症治疗“附加组件”的“红绿灯”系统。Lan Vuong 报告了来自 Ferring、Merck 和 Merck Sharp and Dohme 的咨询和会议费用。其余作者声明与目前的工作没有竞争利益。所有作者都已填写披露表。试用注册号 不适用。
更新日期:2021-01-01
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