目的:病毒感染或疾病患者的医学辅助生殖(MAR)的推荐管理方法是什么?
结论:ESHRE关于病毒感染/疾病患者MAR的指南在预防水平和垂直传播之前提出了78项建议,在3月期间和之后,以及对其结果的影响,这些建议还包括关于对病毒感染检测呈阳性的配子和胚胎的加工和储存的实验室安全性的建议。
背景:新的和改进的抗病毒药物的开发导致病毒感染/疾病患者的预期寿命和生活质量的提高。生育年龄的患者越来越多地探索家庭创造的选择。
UNASSIGNED:该指南是根据ESHRE指南制定的结构化方法制定的。在制定了六种病毒(乙型肝炎病毒,丙型肝炎病毒,人类免疫缺陷病毒,人乳头瘤病毒,人类嗜T淋巴细胞病毒I/II和寨卡病毒)由一组专家,进行了文献检索和评估.评论中包含了截至2020年11月2日发表的英文论文。证据是由女性分析的,男性或夫妇的病毒检测呈阳性。
方法:根据收集的证据,我们制定并讨论了相关建议,直至指南小组达成共识.指南开发小组(GDG)有61个关键问题需要回答,其中12个作为叙述性问题回答,49个作为PICO(患者,干预,比较,结果)问题。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:本指南旨在帮助提供者满足对生育诊所中出现的病毒感染/疾病患者管理的指导日益增长的需求。该指南就预防MAR之前和期间的病毒传播提出了78项建议,以及减少/避免垂直传播给新生儿的干预措施。描述了优选的MAR治疗和干预措施以及病毒感染对结果的影响。GDG制定了44项基于证据的建议-其中37项被制定为强有力的建议,7项被制定为弱项-33项良好实践要点(3GPP)和一项仅研究的建议。在基于证据的建议中,都没有得到高质量证据的支持,两个是中等质量的证据,15个是低质量证据,27个是非常低质量的证据。为了支持病毒感染/疾病患者MAR领域的未来研究,提供了研究建议清单。
结论:纳入的大多数干预措施在病毒感染/疾病患者中没有得到很好的研究。对于很大一部分干预措施,证据非常有限,质量很低。这些干预措施需要更多证据,特别是在人乳头瘤病毒(HPV)领域。这样的未来研究可能需要修订当前的建议。
结论:该指南为临床医生提供了针对病毒感染/疾病患者的MAR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。
背景:该指南由ESHRE制定和资助,支付与指南会议相关的费用,随着文献检索和指南的传播。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。A.D.报告了Ferring和Merck的研究费用,费林的咨询费,在提交的工作之外。C.P.报告默克公司和MSD在提交的作品之外的演讲者费用。K.T.报告了CooperSurgical和Ferring的演讲者费用以及Ferring咨询委员会BioTeam成员的顾问费,在提交的工作之外。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。).
OBJECTIVE: What is the recommended management for medically assisted reproduction (MAR) in patients with a viral infection or disease, based on the best available evidence in the literature?
CONCLUSIONS: The ESHRE guideline on MAR in patients with a viral infection/disease makes 78 recommendations on prevention of horizontal and vertical transmission before, during and after MAR, and the impact on its outcomes, and these also include recommendations regarding laboratory safety on the processing and storage of gametes and embryos testing positive for viral infections.
BACKGROUND: The development of new and improved anti-viral medications has resulted in improved life expectancy and quality of life for patients with viral infections/diseases. Patients of reproductive age are increasingly exploring their options for family creation.
UNASSIGNED: The guideline was developed according to the structured methodology for the development of ESHRE
guidelines. After the formulation of nine key questions for six viruses (hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human papilloma virus, human T-lymphotropic virus I/II and Zika virus) by a group of experts, literature searches and assessments were performed. Papers published up to 2 November 2020 and written in English were included in the review. Evidence was analyzed by female, male or couple testing positive for the virus.
METHODS: Based on the collected evidence, recommendations were formulated and discussed until
consensus was reached within the guideline group. There were 61 key questions to be answered by the guideline development group (GDG), of which 12 were answered as narrative questions and 49 as PICO (Patient, Intervention, Comparison, Outcome) questions. A stakeholder review was organized after the finalization of the draft. The final version was approved by the GDG and the ESHRE Executive Committee.
RESULTS: This guideline aims to help providers meet a growing demand for guidance on the management of patients with a viral infection/disease presenting in the fertility clinic.The guideline makes 78 recommendations on prevention of viral transmission before and during MAR, and interventions to reduce/avoid vertical transmission to the newborn. Preferred MAR treatments and interventions are described together with the effect of viral infections on outcomes. The GDG formulated 44 evidence-based recommendations-of which 37 were formulated as strong recommendations and 7 as weak-33 good practice points (GPP) and one research only recommendation. Of the evidence-based recommendations, none were supported by high-quality evidence, two by moderate-quality evidence, 15 by low-quality evidence and 27 by very low-quality evidence. To support future research in the field of MAR in patients with a viral infection/disease, a list of research recommendations is provided.
CONCLUSIONS: Most interventions included are not well-studied in patients with a viral infection/disease. For a large proportion of interventions, evidence was very limited and of very low quality. More evidence is required for these interventions, especially in the field of human papilloma virus (HPV). Such future studies may require the current recommendations to be revised.
CONCLUSIONS: The guideline provides clinicians with clear advice on best practice in MAR for patients with a viral infection/disease, based on the best evidence currently available. 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, with the literature searches and with the dissemination of the
guideline. The guideline group members did not receive any financial incentives, all work was provided voluntarily. A.D. reports research fees from Ferring and Merck, consulting fees from Ferring, outside the submitted work. C.P. reports speakers fees from Merck and MSD outside the submitted work. K.T. reports speakers fees from Cooper Surgical and Ferring and consultancy fees as member of the advisory board BioTeam of Ferring, outside the submitted work. 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 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.).