目的:对于出现无法解释的不孕症(UI)的夫妇,推荐的治疗方法是什么?基于文献中的最佳证据?
结论:基于证据的UI指南对定义提出了52条建议,诊断,和UI的处理。
背景:UI是在“标准”调查后没有任何女性和男性生殖系统异常的情况下诊断的。然而,诊断工作仍缺乏协商一致的标准化.UI的管理传统上是经验性的。功效,安全,成本,和治疗方案的风险尚未得到强有力的评估。
方法:该指南是根据ESHRE指南的结构化方法制定的。在一组专家提出关键问题之后,文献检索,并进行了评估。对截至2022年10月24日的英文论文进行了评估。
方法:根据现有证据,我们制定并讨论了相关建议,直至指南制定小组(GDG)达成共识.在利益相关者对初稿进行审查之后,最终版本由GDG和ESHRE执行委员会批准.
结果:本指南旨在帮助临床医生为患有UI的夫妇提供最佳护理。由于UI是一种排除诊断,该指南概述了夫妇在不孕症检查期间应该/可以接受的基本诊断程序,并探讨了额外测试的必要性。对于患有UI的夫妇的一线治疗被认为是IUI与卵巢刺激的组合。还评估了治疗UI的其他和替代选择的位置。GDG就UI夫妇的诊断和治疗提出了52条建议。GDG提出了40项基于证据的建议,其中29项作为强有力的建议,11项作为弱建议,10项良好做法要点和两项仅研究建议。在基于证据的建议中,都没有得到高质量证据的支持,一个是中等质量的证据,九是低质量的证据,和31非常低质量的证据。为了支持未来的UI研究,提供了研究建议清单.
结论:大多数额外的诊断测试和干预措施对患有UI的夫妇没有进行过可靠的评估。对于这些测试和治疗的很大一部分,证据非常有限,质量很低。需要更多的证据,未来的研究结果可能会导致当前的建议被修订。
结论:该指南为临床医生提供了关于护理UI夫妇的最佳实践的明确建议,基于现有的最佳证据。此外,提供了一系列研究建议,以刺激该领域的进一步研究。完整的指南和患者传单可在www上获得。eshre.欧盟/指南/UI。
背景:该指南由ESHRE制定,资助指导方针会议的人,文献检索,并与莫纳什大学合作传播该指南,领导了澳大利亚NHMRC生殖生命中妇女健康研究卓越中心(CREWHIRL)。准则小组成员没有获得任何经济奖励;所有工作都是自愿提供的。D.R.报告IBSA和诺和诺德的酬金。B.A.报告来自默克公司的演讲者费用,GedeonRichter,Organon和IntasPharma;是Organon土耳其顾问委员会的一部分,也是土耳其生殖医学协会主席。S.B.报告了默克公司的演讲者费用,Organon,套圈,新加坡妇产科学会和台湾生殖医学学会;编辑和特约作者,MRCOG的生殖医学,剑桥大学出版社;是METAFOR和CAPE试验数据监测委员会的一部分。E.B.报告了罗氏诊断公司的研究资助,GedeonRichter和IBSA;默克公司的演讲者费用,套圈,MSD,罗氏诊断,GedeonRichter,IBSA;E.B.也是Ferring制药顾问委员会的一部分,MSD,罗氏诊断,IBSA,默克,Abbott和GedeonRichter.M.M.报告了MojoFertilityLtd.R.J.N.报告了澳大利亚国家健康与医学研究委员会(NHMRC)的研究资助;FlindersFertilityAdelaide的咨询费,越南河内VinMec医院;默克澳大利亚的演讲者费用,凯迪拉制药印度,费林澳大利亚;主持临床咨询委员会韦斯特米德生育和研究机构MyDuc医院越南。T.P.是芬兰研究委员会的一部分,并报告了罗氏诊断公司的研究资助,NovoNordicsandSigridJuseliusfoundation;consultingfeesfromRocheDiagnosticsandorganon;speaker\'sfeesfromGedeonRichter,罗氏,Exeltis,Organon,Ferring和Korento患者组织;是NFOG的一部分,AE-PCOS协会和几个芬兰协会。S.S.R.报告了罗氏诊断公司的研究资助,Organon,Theramex;Ferring制药公司的咨询费,MSD和Organon;FerringPharmaceuticals的演讲者费用,MSD/Organon,贝辛斯,Theramex,GedeonRichter;GedeonRichter的旅行支持;S.S.R.是TTRANSPORT数据安全监控委员会的成员,也是ESHREART安全与质量特别利益集团的副手;IVILisboa的股票或股票期权,ClínicadeReprodudçãoassistidaLda;设备/医学写作/礼品从罗氏诊断和Ferring制药。S.K.S.报告来自默克公司的演讲者费用,套圈,MSD,药房。HRV报告FerringPharmaceuticals的咨询和差旅费。其他作者没有什么可透露的。
结论:本指南代表了ESHRE的观点,这是在仔细考虑准备时可用的科学证据后获得的。在某些方面缺乏科学证据的情况下,有关ESHRE利益相关者之间已达成共识。遵守这些临床实践指南并不能保证成功或特定的结果。它也没有建立护理标准。临床实践指南并不取代将临床判断应用于每个个体陈述的需要,也不是基于地点和设施类型的变化。ESHRE不做任何担保,明示或暗示,关于临床实践指南,并特别排除对特定用途或目的的适销性和适用性的任何保证。(完整的免责声明可在www。eshre.欧盟/准则。).
What is the recommended management for couples presenting with unexplained infertility (UI), based on the best available evidence in the literature?
The evidence-based guideline on UI makes 52 recommendations on the definition, diagnosis, and treatment of UI.
UI is diagnosed in the absence of any abnormalities of the female and male reproductive systems after \'standard\' investigations. However, a consensual standardization of the diagnostic work-up is still lacking. The management of UI is traditionally empirical. The efficacy, safety, costs, and risks of treatment options have not been subjected to robust evaluation.
The
guideline was developed according to the structured methodology for ESHRE
guidelines. Following formulation of key questions by a group of experts, literature searches, and assessments were undertaken. Papers written in English and published up to 24 October 2022 were evaluated.
Based on the available evidence, recommendations were formulated and discussed until
consensus was reached within the guideline development group (GDG). Following stakeholder review of an initial draft, the final version was approved by the GDG and the ESHRE Executive Committee.
This guideline aims to help clinicians provide the best care for couples with UI. As UI is a diagnosis of exclusion, the guideline outlined the basic diagnostic procedures that couples should/could undergo during an infertility work-up, and explored the need for additional tests. The first-line treatment for couples with UI was deemed to be IUI in combination with ovarian stimulation. The place of additional and alternative options for treatment of UI was also evaluated. The GDG made 52 recommendations on diagnosis and treatment for couples with UI. The GDG formulated 40 evidence-based recommendations-of which 29 were formulated as strong recommendations and 11 as weak-10 good practice points and two research only recommendations. Of the evidence-based recommendations, none were supported by high-quality evidence, one by moderate-quality evidence, nine by low-quality evidence, and 31 by very low-quality evidence. To support future research in UI, a list of research recommendations was provided.
Most additional diagnostic tests and interventions in couples with UI have not been subjected to robust evaluation. For a large proportion of these tests and treatments, evidence was very limited and of very low quality. More evidence is required, and the results of future studies may result in the current recommendations being revised.
The guideline provides clinicians with clear advice on best practice in the care of couples with UI, based on the best evidence currently available. In addition, a list of research recommendations is provided to stimulate further studies in the field. The full
guideline and a patient leaflet are available in www.eshre.eu/
guideline/UI.
The guideline was developed by ESHRE, who funded the guideline meetings, literature searches, and dissemination of the guideline in collaboration with the Monash University led Australian NHMRC Centre of Research Excellence in Women\'s Health in Reproductive Life (CREWHIRL). The guideline group members did not receive any financial incentives; all work was provided voluntarily. D.R. reports honoraria from IBSA and Novo Nordisk. B.A. reports speakers\' fees from Merck, Gedeon Richter, Organon and Intas Pharma; is part of the advisory board for Organon Turkey and president of the Turkish Society of Reproductive Medicine. S.B. reports speakers\' fees from Merck, Organon, Ferring, the Ostetric and Gynaecological Society of Singapore and the Taiwanese Society for Reproductive Medicine; editor and contributing author, Reproductive Medicine for the MRCOG, Cambridge University Press; is part of the METAFOR and CAPE trials data monitoring committee. E.B. reports research grants from Roche diagnostics, Gedeon Richter and IBSA; speaker\'s fees from Merck, Ferring, MSD, Roche Diagnostics, Gedeon Richter, IBSA; E.B. is also a part of an Advisory Board of Ferring Pharmaceuticals, MSD, Roche Diagnostics, IBSA, Merck, Abbott and Gedeon Richter. M.M. reports consulting fees from Mojo Fertility Ltd. R.J.N. reports research grant from Australian National Health and Medical Research Council (NHMRC); consulting fees from Flinders Fertility Adelaide, VinMec Hospital Hanoi Vietnam; speaker\'s fees from Merck Australia, Cadilla Pharma India, Ferring Australia; chair clinical advisory committee Westmead Fertility and research institute MyDuc Hospital Vietnam. T.P. is a part of the Research Council of Finland and reports research grants from Roche Diagnostics, Novo Nordics and Sigrid Juselius foundation; consulting fees from Roche Diagnostics and organon; speaker\'s fees from Gedeon Richter, Roche, Exeltis, Organon, Ferring and Korento patient organization; is a part of NFOG, AE-PCOS society and several Finnish associations. S.S.R. reports research grants from Roche Diagnostics, Organon, Theramex; consulting fees from Ferring Pharmaceuticals, MSD and Organon; speaker\'s fees from Ferring Pharmaceuticals, MSD/Organon, Besins, Theramex, Gedeon Richter; travel support from Gedeon Richter; S.S.R. is part of the Data Safety Monitoring Board of TTRANSPORT and deputy of the ESHRE Special Interest Group on Safety and Quality in ART; stock or stock options from IVI Lisboa, Clínica de Reprodução assistida Lda; equipment/medical writing/gifts from Roche Diagnostics and Ferring Pharmaceuticals. S.K.S. reports speakers\' fees from Merck, Ferring, MSD, Pharmasure. HRV reports consulting and travel fees from Ferring Pharmaceuticals. The other authors have nothing to disclose.
This guideline represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a
consensus between the relevant ESHRE stakeholders has been obtained. Adherence to these clinical practice guidelines does not guarantee a successful or specific outcome, nor does it establish a standard of care. Clinical practice guidelines do not replace the need for application of clinical judgment to each individual presentation, nor variations based on locality and facility type. ESHRE makes no warranty, express or implied, regarding the clinical practice guidelines and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. (Full disclaimer available at www.eshre.eu/
guidelines.).