King's Fertility, Fetal Medicine Research Institute, London, UK.
Institute for Women's Health, University College London, London, UK.
Hum Reprod. 2020 Dec 1;35(12):2715-2724. doi: 10.1093/humrep/deaa242.
Can the priorities for future research in infertility be identified?
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.
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.
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 was 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 judgment and arbitrary consensus definitions.
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. G.D.A. 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. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. A.W.H. 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.L.H. reports grants from Merck, grants from Myovant, grants from Bayer, outside the submitted work and ownership in Embrace Fertility, a private fertility company. N.P.J. reports research sponsorship from AbbVie and Myovant Sciences and consultancy fees from Guerbet, Myovant Sciences, Roche Diagnostics and Vifor Pharma. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from AbbVie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. E.H.Y.N. reports research sponsorship from Merck. C.N. 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. J.S. 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. A.S. reports consultancy fees from Guerbet. J.W. reports being a statistical editor for the Cochrane Gynaecology and Fertility Group. A.V. reports that he is a Statistical Editor of the Cochrane Gynaecology & Fertility Review Group and the journal Reproduction. His employing institution has received payment from Human Fertilisation and Embryology Authority for his advice on review of research evidence to inform their 'traffic light' system for infertility treatment 'add-ons'. N.L.V. 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.
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未来不孕不育研究的重点是什么？
确定了男性不育、女性和不明原因不育、辅助生殖和伦理、获取和组织不孕患者护理这四个领域的前 10 项研究重点。
许多关于预防、管理和不孕不育后果的基本问题仍然没有答案。这是改善有生育问题的人所接受的护理的一个障碍。
研究设计、规模、持续时间：从最初的国际调查、对临床实践指南的系统评价和 Cochrane 系统评价中收集了潜在的研究问题。在一个临时的国际调查中，对已确认的不确定因素进行了合理化的优先排序。在一个共识发展会议上，利用正式的共识发展方法——改良的名义群体技术，不同利益攸关方确定了男性不育、女性和不明原因不育、辅助生殖和伦理、获取和组织不孕患者护理这四个类别的前 10 项研究重点。
参与者/材料、设置、方法：医疗保健专业人员、有生育问题的人和其他人（医疗保健资金提供者、医疗保健提供者、医疗保健监管机构、研究资助机构和研究人员）通过使用由 James Lind 联盟倡导的正式共识方法聚集在一起，进行了公开和透明的过程。
最初的调查由来自 40 个国家的 388 名参与者完成，提交了 423 个潜在的研究问题。14 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。一个由 231 个确认的研究不确定性组成的合理化清单被输入到由来自 43 个国家的 317 名受访者完成的临时优先级调查中。男性不育、女性和不明原因不育（包括与年龄相关的不育、卵巢囊肿、子宫腔异常和输卵管因素不育）、辅助生殖（包括卵巢刺激、IUI 和 IVF）以及伦理、获取和组织护理这四个类别的前 10 项研究重点是在一次共识发展会议上确定的，该会议有来自 11 个国家的 41 名参与者参加。这些研究重点是多种多样的，旨在回答预防、治疗和不孕不育的长期影响等问题。它们强调了追求经常被忽视的研究的重要性，包括解决不孕不育的情感和心理影响、改善特别是在资源较少的环境中获得生育治疗的机会以及确保适当的监管。解决这些重点将需要多样化的研究方法，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、谨慎的原因：我们使用了共识发展方法，该方法存在内在的局限性，包括参与者样本的代表性、基于专业判断的方法决策以及任意的共识定义。
我们预计，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最紧迫的临床需求的研究重点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。
研究资助/利益冲突：该研究由奥克兰医学研究基金会、催化基金、新西兰皇家学会和 Maurice 和 Phyllis Paykel 信托基金资助。G.D.A. 报告说他的研究受到 Abbott 的赞助，有来自 Abbott 和 LabCorp 的个人酬金，在 Advanced Reproductive Care 中有财务利益，是 FIGO 生殖医学委员会、国际辅助生殖技术监测委员会、国际生殖协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，Abbott 和 Ferring 赞助了国际辅助生殖技术监测委员会的研究。Siladitya Bhattacharya 报告说他是 Human Reproduction Open 的主编和 Cochrane Gynaecology and Fertility Group 的编辑。J.L.H.E. 报告说他是 Human Reproduction 的前任主编。A.W.H. 报告说他的研究受到首席科学家办公室、Ferring、医学研究委员会、国家健康与福利研究所和妇女福利组织的资助，是 AbbVie、Ferring、Nordic Pharma 和 Roche Diagnostics 的顾问。M.L.H. 报告说他从 Merck、Myovant 和 Bayer 获得了拨款，从 Embrace Fertility（一家私人生育公司）获得了所有权。N.P.J. 报告说他从 AbbVie 和 Myovant Sciences 获得了研究资助，从 Guerbet、Myovant Sciences、Roche Diagnostics 和 Vifor Pharma 获得了咨询费。J.M.L.K. 报告说他从 Ferring 和 Theramex 获得了研究资助。R.S.L. 报告说他从 AbbVie、Bayer、Ferring、Fractyl、Insud Pharma 和 Kindex 获得了咨询费，从 Guerbet 获得了研究资助。B.W.M. 报告说他从 Guerbet、iGenomix、Merck、Merck KGaA 和 ObsEva 获得了咨询费。E.H.Y.N. 报告说他从 Merck 获得了研究资助。C.N. 报告说他是 Fertility and Sterility 的共同主编和 Journal of Urology 的章节编辑，他从 Ferring 获得了赞助，保留了对 NexHand 的财务利益。J.S. 报告说他受雇于一家国家卫生服务生育诊所，从 Merck 获得了教育活动的咨询费，从 Ferring 获得了参加生育会议的赞助，是 Human Fertility 的临床副编辑。A.S. 报告说他从 Guerbet 获得了咨询费。J.W. 报告说他是 Cochrane Gynaecology & Fertility Review Group 的统计编辑和 Reproduction 杂志的统计编辑。他所在的机构从人类受精和胚胎管理局获得了关于审查研究证据的建议，以告知他们的“红绿灯”系统，该系统用于评估“附加”生育治疗的“附加”治疗。N.L.V. 报告说他从 Ferring、Merck 和 Merck Sharp and Dohme 获得了咨询费和会议费。其余作者声明与目前的工作没有竞争利益。所有作者都已完成披露表。
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