目的:如何定义和管理接受ART治疗的患者反复植入失败(RIF)?
结论:这是第一篇ESHRE良好实践建议文件,提供了RIF的定义以及如何调查原因和影响因素的建议,以及如何提高怀孕的机会。
背景:RIF在ART诊所是一个挑战,通过在临床实践中提供和应用的大量调查和干预措施,通常没有生物学理由或有明确的益处证据。
■本文档是根据ESHRE良好实践建议的预定义方法制定的。建议得到了文献数据的支持,如果可用,以及先前发表的关于RIF临床实践的调查结果和工作组的专业知识。在PubMed和Cochrane进行了文献检索,重点是“复发性生殖失败”,\'复发性植入失败\',和“反复植入失败”。
方法:ESHRE复发性种植失败工作组包括代表ESHRE种植和早孕特殊兴趣小组的八名成员,生殖内分泌学,和胚胎学,拥有独立主席和统计学专家。根据工作组的专家意见,制定了临床实践建议,同时考虑到已发表的数据和临床实践中吸收调查的结果。该文件草案随后向ESHRE成员开放,供在线同行审查,并根据收到的意见进行了修订。
结果:工作组建议将RIF视为ART的次要现象,因为它只能在接受IVF的患者中观察到,并应采用以下RIF的描述:“RIF描述了被认为可行的胚胎移植未能在特定患者中足够频繁地导致妊娠试验阳性的情况,因此需要考虑进一步的研究和/或干预措施。”一致认为,用于确定RIF以启动进一步研究的累积预测植入机会的推荐阈值为60%。当一对夫妇没有通过一定数量的胚胎移植成功植入,并且与该数量相关的累积预测植入机会大于60%时,然后,他们应该就进一步的调查和/或治疗方案提供咨询。该术语定义了临床RIF,应考虑采取进一步措施。在怀疑RIF时,就调查提出了十九项建议,13、干预措施。根据是否推荐调查/干预措施,对建议进行颜色编码(绿色),被认为是(橙色),或不推荐,即不提供常规(红色)。
结论:在等待进一步研究和试验的结果时,ESHRE复发性植入失败工作组建议,根据个体患者或夫妇成功植入的机率来确定RIF,并将调查和治疗限制在明确的理由和数据表明其可能获益的支持范围内.
结论:本文不仅提供了良好的实践建议,还重点介绍了需要进一步研究的调查和干预措施。这项研究,当行为良好时,将是RIF临床管理取得进展的关键。
背景:本项目的会议和技术支持由ESHRE资助。N.M.宣布了ArtPRED(荷兰)和FreyaBiosciences(丹麦)的咨询费;GedeonRichter讲座的荣誉,默克,雅培,和IBSA;是VersoBiosense的联合创始人。他是生殖生物医学在线(RBMO)的联合主编。D.C.宣布为《人类繁殖更新》的副编辑,并宣布默克公司的演讲酬金,Organon,IBSA,和公平;支持参加库珀外科会议,富士胶片欧文科学公司。G.G.宣布他或他的机构获得了研究的财政或非财政支持,讲座,工作坊,咨询角色,或者从Ferring出发,默克,Gedeon-Richter,PregLem,雅培,Vifor,Organon,MSD,合作外科,ObsEVA,ReprodWissen他是《妇产科和生殖生物医学在线档案》杂志的编辑,和《GynäkologischeEndokrinologie》杂志主编。他参与了国家和国际层面的指南开发和质量控制。G.L.宣布他或他的机构获得默克公司讲座的酬金,套圈,Vianex/Organon,和MSD。他是《人类繁殖更新》的副主编,ESHRE生殖内分泌学特别兴趣小组协调员,并参与了ESHRE和国家生育当局的指导发展小组。D.J.M.宣布为人类生殖开放和生殖生物医学在线统计顾问的副编辑。B.T.宣布为Reprognostics的股东,她或她的机构获得了财政或非财政支持的研究,临床试验,讲座,工作坊,顾问角色或来自Ferring参加会议的支持,MSD,Exeltis,默克·塞罗诺,拜耳,Teva,Theramex和诺华,Astropharm,Ferring.其他作者没有什么可透露的。
结论:本良好实践建议(GPR)文件代表了ESHRE的观点,这是相关ESHRE利益相关者之间达成共识的结果,并且基于准备时可用的科学证据。ESHREGPR应用于信息和教育目的。它们不应被解释为设定护理标准或被视为包括所有适当的护理方法,或排除其他合理旨在获得相同结果的护理方法。它们并不能取代将临床判断应用于每个个体表现的需要,或基于地点和设施类型的变化。此外,ESHREGPR并不构成或暗示认可,或者偏爱,ESHRE包含的任何技术。
OBJECTIVE: How should recurrent implantation failure (RIF) in patients undergoing ART be defined and managed?
CONCLUSIONS: This is the first ESHRE good practice recommendations paper providing a definition for RIF together with recommendations on how to investigate causes and contributing factors, and how to improve the chances of a pregnancy.
BACKGROUND: RIF is a challenge in the ART clinic, with a multitude of investigations and interventions offered and applied in clinical practice, often without biological rationale or with unequivocal evidence of benefit.
UNASSIGNED: This document was developed according to a predefined methodology for ESHRE good practice recommendations. Recommendations are supported by data from the literature, if available, and the results of a previously published survey on clinical practice in RIF and the expertise of the working group. A literature search was performed in PubMed and Cochrane focussing on \'recurrent reproductive failure\', \'recurrent implantation failure\', and \'repeated implantation failure\'.
METHODS: The ESHRE Working Group on Recurrent Implantation Failure included eight members representing the ESHRE Special Interest Groups for Implantation and Early Pregnancy, Reproductive Endocrinology, and Embryology, with an independent chair and an expert in statistics. The recommendations for clinical practice were formulated based on the expert opinion of the working group, while taking into consideration the published data and results of the survey on uptake in clinical practice. The draft document was then open to ESHRE members for online peer review and was revised in light of the comments received.
RESULTS: The working group recommends considering RIF as a secondary phenomenon of ART, as it can only be observed in patients undergoing IVF, and that the following description of RIF be adopted: \'RIF describes the scenario in which the transfer of embryos considered to be viable has failed to result in a positive pregnancy test sufficiently often in a specific patient to warrant consideration of further investigations and/or interventions\'. It was agreed that the recommended threshold for the cumulative predicted chance of implantation to identify RIF for the purposes of initiating further investigation is 60%. When a couple have not had a successful implantation by a certain number of embryo transfers and the cumulative predicted chance of implantation associated with that number is greater than 60%, then they should be counselled on further investigation and/or treatment options. This term defines clinical RIF for which further actions should be considered. Nineteen recommendations were formulated on investigations when RIF is suspected, and 13 on interventions. Recommendations were colour-coded based on whether the investigations/interventions were recommended (green), to be considered (orange), or not recommended, i.e. not to be offered routinely (red).
CONCLUSIONS: While awaiting the results of further studies and trials, the ESHRE Working Group on Recurrent Implantation Failure recommends identifying RIF based on the chance of successful implantation for the individual patient or couple and to restrict investigations and treatments to those supported by a clear rationale and data indicating their likely benefit.
CONCLUSIONS: This article provides not only good practice advice but also highlights the investigations and interventions that need further research. This research, when well-conducted, will be key to making progress in the clinical management of RIF.
BACKGROUND: The meetings and technical support for this project were funded by ESHRE. N.M. declared consulting fees from ArtPRED (The Netherlands) and Freya Biosciences (Denmark); Honoraria for lectures from Gedeon Richter, Merck, Abbott, and IBSA; being co-founder of Verso Biosense. He is Co-Chief Editor of Reproductive Biomedicine Online (RBMO). D.C. declared being an Associate Editor of Human Reproduction Update, and declared honoraria for lectures from Merck, Organon, IBSA, and Fairtility; support for attending meetings from Cooper Surgical, Fujifilm Irvine Scientific. G.G. declared that he or his institution received financial or non-financial support for research, lectures, workshops, advisory roles, or travelling from Ferring, Merck, Gedeon-Richter, PregLem, Abbott, Vifor, Organon, MSD, Coopersurgical, ObsEVA, and ReprodWissen. He is an Editor of the journals Archives of Obstetrics and Gynecology and Reproductive Biomedicine Online, and Editor in Chief of Journal Gynäkologische Endokrinologie. He is involved in guideline developments and quality control on national and international level. G.L. declared he or his institution received honoraria for lectures from Merck, Ferring, Vianex/Organon, and MSD. He is an Associate Editor of Human Reproduction Update, immediate past Coordinator of Special Interest Group for Reproductive Endocrinology of ESHRE and has been involved in Guideline Development Groups of ESHRE and national fertility authorities. D.J.M. declared being an Associate Editor for Human Reproduction Open and statistical Advisor for Reproductive Biomedicine Online. B.T. declared being shareholder of Reprognostics and she or her institution received financial or non-financial support for research, clinical trials, lectures, workshops, advisory roles or travelling from support for attending meetings from Ferring, MSD, Exeltis, Merck Serono, Bayer, Teva, Theramex and Novartis, Astropharm, Ferring. The other authors had nothing to disclose.
CONCLUSIONS: This Good Practice Recommendations (GPR) document represents the views of ESHRE, which are the result of consensus between the relevant ESHRE stakeholders and are based on the scientific evidence available at the time of preparation. ESHRE GPRs should be used for information and educational purposes. They should not be interpreted as setting a standard of care or be deemed inclusive of all proper methods of care, or be exclusive of other methods of care reasonably directed to obtaining the same results. They do not replace the need for application of clinical judgement to each individual presentation, or variations based on locality and facility type. Furthermore, ESHRE GPRs do not constitute or imply the endorsement, or favouring, of any of the included technologies by ESHRE.