Department Reproductive Medicine, Sahlgrenska University Hospital, Göteborg, Sweden.
The Fertility Department, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.
Hum Reprod. 2023 Nov 2;38(11):2062-2104. doi: 10.1093/humrep/dead184.
Which add-ons are safe and effective to be used in ART treatment?
Forty-two recommendations were formulated on the use of add-ons in the diagnosis of fertility problems, the IVF laboratory and clinical management of IVF treatment.
The innovative nature of ART combined with the extremely high motivation of the patients has opened the door to the wide application of what has become known as 'add-ons' in reproductive medicine. These supplementary options are available to patients in addition to standard fertility procedures, typically incurring an additional cost. A diverse array of supplementary options is made available, encompassing tests, drugs, equipment, complementary or alternative therapies, laboratory procedures, and surgical interventions. These options share the common aim of stating to enhance pregnancy or live birth rates, mitigate the risk of miscarriage, or expedite the time to achieving pregnancy.
STUDY DESIGN, SIZE, DURATION: ESHRE aimed to develop clinically relevant and evidence-based recommendations focusing on the safety and efficacy of add-ons currently used in fertility procedures in order to improve the quality of care for patients with infertility.
PARTICIPANTS/MATERIALS, SETTING, METHODS: ESHRE appointed a European multidisciplinary working group consisting of practising clinicians, embryologists, and researchers who have demonstrated leadership and expertise in the care and research of infertility. Patient representatives were included in the working group. To ensure that the guidelines are evidence-based, the literature identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, recommendations were based on the professional experience and consensus of the working group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 46 independent international reviewers. A total of 272 comments were received and incorporated where relevant.
The multidisciplinary working group formulated 42 recommendations in three sections; diagnosis and diagnostic tests, laboratory tests and interventions, and clinical management.
LIMITATIONS, REASONS FOR CAUTION: Of the 42 recommendations, none could be based on high-quality evidence and only four could be based on moderate-quality evidence, implicating that 95% of the recommendations are supported only by low-quality randomized controlled trials, observational data, professional experience, or consensus of the development group.
These guidelines offer valuable direction for healthcare professionals who are responsible for the care of patients undergoing ART treatment for infertility. Their purpose is to promote safe and effective ART treatment, enabling patients to make informed decisions based on realistic expectations. The guidelines aim to ensure that patients are fully informed about the various treatment options available to them and the likelihood of any additional treatment or test to improve the chance of achieving a live birth.
STUDY FUNDING/COMPETING INTEREST(S): All costs relating to the development process were covered from ESHRE funds. There was no external funding of the development process or manuscript production. K.L. reports speakers fees from Merck and was part of a research study by Vitrolife (unpaid). T.E. reports consulting fees from Gynemed, speakers fees from Gynemed and is part of the scientific advisory board of Hamilton Thorne. N.P.P. reports grants from Merck Serono, Ferring Pharmaceutical, Theramex, Gedeon Richter, Organon, Roche, IBSA and Besins Healthcare, speakers fees from Merck Serono, Ferring Pharmaceutical, Theramex, Gedeon Richter, Organon, Roche, IBSA and Besins Healthcare. S.R.H. declares being managing director of Fertility Europe, a not-for-profit organization receiving financial support from ESHRE. I.S. is a scientific advisor for and has stock options from Alife Health, is co-founder of IVFvision LTD (unpaid) and received speakers' fee from the 2023 ART Young Leader Prestige workshop in China. A.P. reports grants from Gedeon Richter, Ferring Pharmaceuticals and Merck A/S, consulting fees from Preglem, Novo Nordisk, Ferring Pharmaceuticals, Gedeon Richter, Cryos and Merck A/S, speakers fees from Gedeon Richter, Ferring Pharmaceuticals, Merck A/S, Theramex and Organon, travel fees from Gedeon Richter. The other authors disclosed no conflicts of interest.
This Good Practice Recommendations (GPRs) 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 bedeemedinclusive of all proper methods of care, or be exclusive of other methods of care reasonably directed to obtaining the same results.Theydo 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.
哪些附加物在辅助生殖技术（ART）治疗中是安全有效的？
针对生育问题的诊断、体外受精（IVF）实验室和临床管理，制定了 42 条关于附加物使用的建议。
ART 的创新性以及患者极高的治疗动机，为生殖医学中所谓的“附加物”的广泛应用打开了大门。这些补充选择是在标准生育程序之外提供给患者的，通常会产生额外的费用。提供了各种各样的补充选择，包括测试、药物、设备、补充或替代疗法、实验室程序和手术干预。这些选择的共同目标是提高怀孕或活产率、降低流产风险或加快怀孕时间。
研究设计、规模和持续时间：欧洲人类生殖与胚胎学学会（ESHRE）旨在制定具有临床相关性和循证依据的建议，重点关注当前在生育程序中使用的附加物的安全性和有效性，以提高不孕患者的护理质量。
参与者/材料、设置、方法：ESHRE 任命了一个由有实践经验的临床医生、胚胎学家和研究人员组成的欧洲多学科工作组，他们在不孕不育的护理和研究方面表现出领导力和专业知识。患者代表也加入了工作组。为确保指南具有循证依据，对从系统搜索中确定的文献进行了审查和批判性评估。在缺乏明确科学证据的情况下，建议基于工作组的专业经验和共识。因此，该指南基于现有最佳证据和专家一致意见。在发布之前，该指南由 46 名独立的国际审稿人进行了审查。共收到 272 条评论，并在相关情况下进行了采纳。
多学科工作组在三个部分制定了 42 条建议；诊断和诊断测试、实验室测试和干预、临床管理。
局限性、谨慎的原因：在这 42 条建议中，没有一条可以基于高质量的证据，只有四条可以基于中等质量的证据，这意味着 95%的建议仅基于低质量的随机对照试验、观察性数据、专业经验或发展小组的共识。
这些指南为负责接受辅助生殖技术治疗不孕的患者的医疗保健专业人员提供了宝贵的指导。其目的是促进安全有效的辅助生殖技术治疗，使患者能够基于现实的期望做出明智的决定。这些指南旨在确保患者充分了解他们可用的各种治疗选择以及任何额外治疗或测试以提高活产率的可能性。
研究资金/利益冲突：开发过程中涉及的所有费用均由 ESHRE 承担。开发过程或手稿制作没有外部资金。K.L. 报告说从默克公司获得演讲费，并参与了 Vitrolife 的研究（无薪）。T.E. 报告说从 Gynemed 获得咨询费，从 Gynemed 获得演讲费，并担任 Hamilton Thorne 的科学顾问委员会成员。N.P.P. 报告说从默克 Serono、Ferring 制药、Theramex、Gedeon Richter、Organon、Roche、IBSA 和 Besins Healthcare 获得拨款，从 Merck Serono、Ferring 制药、Theramex、Gedeon Richter、Organon、Roche、IBSA 和 Besins Healthcare 获得演讲费。S.R.H. 是 Fertility Europe 的常务董事，这是一个非营利组织，从 ESHRE 获得财政支持。I.S. 是 Alife Health 的科学顾问，是 IVFvision LTD 的联合创始人（无薪），并从中国 2023 年 ART 青年领袖风采研讨会获得演讲费。A.P. 报告说从 Gedeon Richter、Ferring Pharmaceuticals 和 Merck A/S 获得拨款，从 Preglem、Novo Nordisk、Ferring Pharmaceuticals、Gedeon Richter、Cryos 和 Merck A/S 获得咨询费，从 Gedeon Richter、Ferring Pharmaceuticals、Merck A/S、Theramex 和 Organon 获得演讲费，从 Gedeon Richter 获得旅行费。其他作者没有披露利益冲突。
本良好实践建议（GPR）文件代表 ESHRE 的观点，是相关 ESHRE 利益相关者之间达成共识的结果，并且基于编写时的可用科学证据。ESHRE GPR 应仅供信息和教育目的使用。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，也不应排除其他旨在获得相同结果的合理护理方法。它们不能替代对每个个体表现的应用临床判断，也不能基于地点和设施类型进行调整。此外，ESHRE GPR 不构成或暗示 ESHRE 对所包括的任何技术的认可或支持。
