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.
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.
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.
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.
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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男性不育症四个领域的十大研究重点,女性和无法解释的不孕症,医学辅助生殖和伦理,确定了有生育问题的人的护理机会和组织。
关于预防的许多基本问题,不孕症的管理和后果仍未解决。这是改善那些有生育问题的人所接受的护理的障碍。
从最初的国际调查中整理了潜在的研究问题,临床实践指南和Cochrane系统评价的系统评价。在一项临时国际调查中,已确认的研究不确定性的合理化清单被优先考虑。在共识发展会议上讨论了优先研究的不确定性。使用正式的共识开发方法,修改后的名义分组技术,不同的利益相关者确定了每个类别男性不育的十大研究重点,女性和无法解释的不孕症,医学辅助生殖和伦理,获得和组织护理。
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,医疗保健监管机构,研究资助机构和研究人员)采用詹姆斯·林德联盟倡导的正式共识方法,在公开透明的过程中聚集在一起。
最初的调查由来自40个国家的388名参与者完成,并提交了423个潜在的研究问题。14个临床实践指南和162个Cochrane系统评价确定了另外236个潜在的研究问题。来自43个国家/地区的317名受访者完成了一项临时优先顺序调查,其中包括231个已确认的研究不确定性的合理化清单。四类男性不育症的十大研究重点,女性和无法解释的不孕症(包括与年龄相关的不孕症,卵巢囊肿,子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)和道德,在有来自11个国家的41名与会者参加的共识发展会议上确定了护理的获取和组织。这些研究重点是多种多样的,并寻求有关预防问题的答案,治疗和不孕症的长期影响。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感和心理影响,改善获得生育治疗的机会,特别是在较低的资源环境和确保适当的监管。解决这些优先事项将需要不同的研究方法,包括基于实验室的科学,定性和定量研究以及人口科学。
我们使用了共识开发方法,有固有的局限性,包括参与者样本的代表性,以专业判断和任意共识定义为依据的方法论决策。
我们预计确定的研究重点,专门为突出医疗保健专业人员认为的最紧迫的临床需求而开发,有生育问题的人和其他人,将帮助研究资助组织和研究人员制定他们未来的研究议程。
这项研究由奥克兰医学研究基金会资助,催化剂基金,新西兰皇家学会和莫里斯和菲利斯·帕克尔信托基金。G.D.A.报告雅培的研究赞助,雅培和LabCorp的个人费用,对高级生殖保健有经济兴趣,FIGO生殖医学委员会成员,国际辅助生殖技术监测委员会,国际生育协会联合会和世界子宫内膜异位症研究基金会,以及雅培和费林国际辅助生殖技术监测委员会的研究赞助。SiladityaBhattacharya报告说,他是人类生殖公开赛的主编,也是科克伦妇科和生育小组的编辑。J.L.H.E.是《人类生殖》名誉编辑.A.W.H.报告了首席科学家办公室的研究赞助,套圈,医学研究理事会,国家健康研究和妇女福利研究所和AbbVie的咨询费,套圈,北欧制药和罗氏诊断。M.L.H.报告了默克公司的赠款,Myovant的赠款,来自拜耳的赠款,在《拥抱生育》中提交的工作和所有权之外,一家私人生育公司.N.P.J.报告了AbbVie和MyovantSciences的研究赞助以及Guerbet的咨询费,MyovantSciences,罗氏诊断和ViforPharma。J.M.L.K.报告了Ferring和Theramex的研究赞助。R.S.L.报告了AbbVie的咨询费,拜耳,套圈,Fractyl,InsudPharma和Kindex以及Guerbet和HassAvocado董事会的研究赞助。B.W.M.报告Guerbet的顾问费,iGenomix,默克,默克KGaA和ObsEva.E.H.Y.N.报告了默克公司的研究赞助。C.N.报告是《生育和不育》的联合主编和《泌尿外科杂志》的部门编辑,费林的研究赞助,并保留了NexHand的经济利益。J.S.报告被国家卫生服务生育诊所雇用,默克公司教育活动的咨询费,赞助参加费林的生育会议,并成为人类生育的临床代言人。A.S.报告了Guerbet的咨询费。J.W.报告是科克伦妇科和生育小组的统计编辑。A.V.报告说,他是Cochrane妇科与生育评论小组和《生殖》杂志的统计编辑。他的雇用机构已从人类受精和胚胎学管理局获得了有关研究证据审查的建议,以告知他们的“交通信号灯”不育治疗系统“附件”。N.L.V.报告费林的咨询和会议费,默克、默克夏普和多姆。其余作者宣布与当前工作没有竞争利益。所有作者都填写了披露表格。
不适用。