目的:应用双胚胎移植(DET)而不是选择性单胚胎移植(eSET)应考虑哪些临床和胚胎因素?
结论:没有临床或胚胎因素本身证明在IVF/ICSI中推荐DET代替eSET是合理的。
背景:DET与较高的多胎妊娠率相关,导致母婴并发症的增加。这些并发症包括早产,低出生体重,和其他围产期不良结局。为了减轻与多胎妊娠相关的风险,eSET被国际和国家专业组织推荐为ART的首选方法。
方法:该指南是根据ESHRE指南的开发和更新的结构化方法制定的。在PUBMED/MEDLINE和Cochrane数据库中进行文献检索,和相关论文发表到2023年5月,用英语写的,包括在内。活产率,累计活产率,多胎妊娠率被认为是关键结局.
方法:根据收集的证据,在指南制定小组(GDG)内达成共识之前,我们对相关建议进行了讨论.准则草案定稿后,组织了一次利益攸关方审查。最终版本由GDG和ESHRE执行委员会批准。
结果:该指南提供了35条关于多胎妊娠相关的医学和非医学风险以及决定移植胚胎数量时要考虑的临床和胚胎因素的建议。这些建议包括25项循证建议,其中24项作为强有力的建议,一项作为有条件的建议,和10个好的练习点。在基于证据的建议中,7例(28%)获得中等质量证据支持.其余的建议得到较低的支持(三项建议;12%),或非常低质量的证据(15条建议;60%)。由于缺乏循证研究,该指南还明确提到了对未来研究的建议.
结论:该指南根据现有证据逐一评估了不同的因素。然而,在现实生活中,临床医生的决定是基于与每个患者病例相关的几个预后因素。此外,随机对照试验的证据太匮乏,无法制定高质量的循证建议.
结论:该指南为卫生专业人员提供了关于IVF/ICSI决策过程中最佳实践的明确建议。根据现有的最佳证据,以及应传达给患者的相关信息的建议。此外,提供了一系列研究建议,以刺激该领域的进一步研究。
背景:该指南由ESHRE制定和资助,支付与指南会议相关的费用,文献检索,以及指导方针的传播。准则组成员未收到付款。DPB宣布获得默克公司讲座的酬金,套圈,还有GedeonRichter.她是ESHREEXCO的成员,地中海生殖医学学会和克罗地亚妇科内分泌学和生殖医学学会主席。CDG是ESHREEIM联盟的前任主席,也是人类生殖编辑委员会的带薪副成员。IR宣布收到ESHRE和EDCD出席会议的报销。她在OBBCSSR担任无薪领导角色,ECDCSohonet,和AER。KAR-W宣布接受瑞典癌症协会对临床研究人员的资助和对该机构的资助(200170F),高级临床研究者奖,福斯金斯方德(Dnr:201313),斯德哥尔摩县议会FoU(FoUI-953912)和卡罗林斯卡学院(Dnr2020-01963),NovoNordisk,默克和费林制药。她从瑞典卫生和福利部获得了咨询费。她收到了罗氏的酬金,辉瑞,和组织主席和讲座。她参加会议得到了Organon的支持。她参加了默克公司的顾问委员会,北欧国家,还有Ferring.她宣布从默克制药公司和Ferring公司获得延时设备和赠款,并向临床前研究机构付款。SS-R获得了罗氏诊断公司的研究资助,Organon/MSD,Theramex,还有Gedeo-Richter.他从Organon/MSD获得咨询费,Ferring制药,和MerckSerono.他宣布接受费林制药公司的演讲酬金,贝辛斯,Organon/MSD,Theramex,还有GedeonRichter.他获得了参加GedeonRichter会议的支持,并参加了T-TRANSPORT试验的数据安全监控委员会。他是ESHRESQART特殊利益集团的副手。他持有IVILisboa的股票期权,并从罗氏诊断和Ferring制药公司获得设备和其他服务。KT宣布收到默克·塞罗诺和Organon举办讲座的酬金。她是EDQM安全顾问委员会的成员。她在ICCBBA董事会中担任领导职务。ZV因参加会议而获得了ESHRE的报销。她还获得了ESHRE和JuhaniAltonen基金会的研究资助。她是EHSRESQART特殊兴趣小组的协调员。其他作者没有利益冲突要声明。
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单独的陈述的需要,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(完整免责声明可在https://www.eshre.欧盟/准则和法律)。
OBJECTIVE: Which clinical and embryological factors should be considered to apply double embryo transfer (DET) instead of elective single embryo transfer (eSET)?
CONCLUSIONS: No clinical or embryological factor per se justifies a recommendation of DET instead of eSET in IVF/ICSI.
BACKGROUND: DET is correlated with a higher rate of multiple pregnancy, leading to a subsequent increase in complications for both mother and babies. These complications include preterm birth, low birthweight, and other perinatal adverse outcomes. To mitigate the risks associated with multiple pregnancy, eSET is recommended by international and national professional organizations as the preferred approach in ART.
METHODS: The guideline was developed according to the structured methodology for development and update of ESHRE guidelines. Literature searches were performed in PUBMED/MEDLINE and Cochrane databases, and relevant papers published up to May 2023, written in English, were included. Live birth rate, cumulative live birth rate, and multiple pregnancy rate were considered as critical outcomes.
METHODS: Based on the collected evidence, recommendations were discussed until a consensus was reached within the Guideline Development Group (GDG). A stakeholder review was organized after the guideline draft was finalized. The final version was approved by the GDG and the ESHRE Executive Committee.
RESULTS: The guideline provides 35 recommendations on the medical and non-medical risks associated with multiple pregnancies and on the clinical and embryological factors to be considered when deciding on the number of embryos to transfer. These recommendations include 25 evidence-based recommendations, of which 24 were formulated as strong recommendations and one as conditional, and 10 good practice points. Of the evidence-based recommendations, seven (28%) were supported by moderate-quality evidence. The remaining recommendations were supported by low (three recommendations; 12%), or very low-quality evidence (15 recommendations; 60%). Owing to the lack of evidence-based research, the guideline also clearly mentions recommendations for future studies.
CONCLUSIONS: The guideline assessed different factors one by one based on existing evidence. However, in real life, clinicians\' decisions are based on several prognostic factors related to each patient\'s case. Furthermore, the evidence from randomized controlled trials is too scarce to formulate high-quality evidence-based recommendations.
CONCLUSIONS: The guideline provides health professionals with clear advice on best practice in the decision-making process during IVF/ICSI, based on the best evidence currently available, and recommendations on relevant information that should be communicated to patients. In addition, a list of research recommendations is provided to stimulate further studies in the field.
BACKGROUND: The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings, the literature searches, and the dissemination of the guideline. The guideline group members did not receive payment. DPB declared receiving honoraria for lectures from Merck, Ferring, and Gedeon Richter. She is a member of ESHRE EXCO, and the Mediterranean Society for reproductive medicine and the president of the Croatian Society for Gynaecological Endocrinology and Reproductive Medicine. CDG is the past Chair of the ESHRE EIM Consortium and a paid deputy member of the Editorial board of Human Reproduction. IR declared receiving reimbursement from ESHRE and EDCD for attending meetings. She holds an unpaid leadership role in OBBCSSR, ECDC Sohonet, and AER. KAR-W declared receiving grants for clinical researchers and funding provision to the institution from the Swedish Cancer Society (200170F), the Senior Clinical Investigator Award, Radiumhemmets Forskningsfonder (Dnr: 201313), Stockholm County Council FoU (FoUI-953912) and Karolinska Institutet (Dnr 2020-01963), NovoNordisk, Merck and Ferring Pharmaceuticals. She received consulting fees from the Swedish Ministry of Health and Welfare. She received honoraria from Roche, Pfizer, and Organon for chairmanship and lectures. She received support from Organon for attending meetings. She participated in advisory boards for Merck, Nordic countries, and Ferring. She declared receiving time-lapse equipment and grants with payment to institution for pre-clinical research from Merck pharmaceuticals and from Ferring. SS-R received research funding from Roche Diagnostics, Organon/MSD, Theramex, and Gedeo-Richter. He received consulting fees from Organon/MSD, Ferring Pharmaceuticals, and Merck Serono. He declared receiving honoraria for lectures from Ferring Pharmaceuticals, Besins, Organon/MSD, Theramex, and Gedeon Richter. He received support for attending Gedeon Richter meetings and participated in the Data Safety Monitoring Board of the T-TRANSPORT trial. He is the Deputy of ESHRE SQART special interest group. He holds stock options in IVI Lisboa and received equipment and other services from Roche Diagnostics and Ferring Pharmaceuticals. KT declared receiving payment for honoraria for giving lectures from Merck Serono and Organon. She is member of the safety advisory board of EDQM. She holds a leadership role in the ICCBBA board of directors. ZV received reimbursement from ESHRE for attending meetings. She also received research grants from ESHRE and Juhani Aaltonen Foundation. She is the coordinator of EHSRE SQART special interest group. The other authors have no conflicts of interest to declare.
CONCLUSIONS: 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 judgement 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 https://www.eshre.eu/Guidelines-and-Legal).