Monash University, Clayton, Victoria, Australia.
University of Amsterdam, Amsterdam, the Netherlands.
Fertil Steril. 2018 Jun;109(6):968-979. doi: 10.1016/j.fertnstert.2018.04.037.
Although most medical treatments are designed for the average patient with a one-size-fits-all-approach, they may not benefit all. Better understanding of the function of genes, proteins, and metabolite, and of personal and environmental factors has led to a call for personalized medicine. Personalized reproductive medicine is still in its infancy, without clear guidance on treatment aspects that could be personalized and on trial design to evaluate personalized treatment effect and benefit-harm balance. While the rationale for a personalized approach often relies on retrospective analyses of large observational studies or real-world data, solid evidence of superiority of a personalized approach will come from randomized trials comparing outcomes and safety between a personalized and one-size-fits-all strategy. A more efficient, targeted randomized trial design may recruit only patients or couples for which the personalized approach would differ from the previous, standard approach. Multiple monocenter studies using the same study protocol (allowing future meta-analysis) might reduce the major center effect associated with multicenter studies. In certain cases, single-arm observational studies can generate the necessary evidence for a personalized approach. This review describes each of the main segments of patient care in assisted reproductive technologies treatment, addressing which aspects could be personalized, emphasizing current evidence and relevant study design.
虽然大多数医疗方法都是针对具有普遍适用性的一般患者设计的，但它们可能并不适用于所有人。对基因、蛋白质和代谢物的功能以及个人和环境因素的更好理解，导致了人们呼吁采用个性化医疗。个性化生殖医学仍处于起步阶段，对于可以个性化的治疗方面以及评估个性化治疗效果和利弊平衡的试验设计，尚无明确的指导。虽然个性化方法的基本原理通常依赖于对大型观察性研究或真实世界数据的回顾性分析，但从比较个性化方法和一刀切策略的结果和安全性的随机试验中，才能获得个性化方法具有优越性的可靠证据。一种更有效、有针对性的随机试验设计可能只招募那些个性化方法与之前的标准方法不同的患者或夫妇。使用相同研究方案的多项单中心研究（允许未来进行荟萃分析）可能会减少与多中心研究相关的主要中心效应。在某些情况下，单臂观察性研究可以为个性化方法提供必要的证据。本综述描述了辅助生殖技术治疗中患者护理的主要环节，探讨了哪些方面可以实现个性化，并强调了当前的证据和相关研究设计。
