UCL Centre for PG&D, Institute for Womens Health, UCL and Centre for Reproductive and Genetic Health, University College London Hospital, London, UK.
Hum Reprod. 2012 Feb;27(2):303-13. doi: 10.1093/humrep/der414. Epub 2011 Dec 12.
There are many examples in assisted reproduction technology, where new technology and methods have been introduced into the clinical setting without appropriate development and evidence-based medicine to show that the procedure is safe and beneficial to the patient. Examples include preimplantation genetic screening, assisted hatching, in vitro maturation, blastocyst transfer and vitrification. Changes to culture media composition, stimulation regimes and laboratory protocols are also often established internationally without adequate validation. More recently, novel equipment that needs to be validated before it enters routine clinical use is being developed for IVF. With technologies such as producing gametes from stem cells around the corner, it is vital to ensure that the necessary research and development is conducted before bringing new techniques into clinical practice. Ideally, this should include preliminary work on animal models, such as mice/rats/rabbits/larger mammals, followed by studies on human embryos donated for research and finally well-designed RCTs with a follow up of all children born from the procedure. If such preliminary studies are not performed and published, it is possible that technology bringing no clinical benefit or leading to adverse health outcomes in the children born by these practices may be introduced. All IVF clinics need to consider the safety and efficacy of new technologies before introducing them.
在辅助生殖技术中有许多例子,新技术和方法被引入临床应用,而没有适当的开发和循证医学来证明该程序对患者是安全和有益的。例如,植入前遗传学筛查、辅助孵化、体外成熟、囊胚转移和玻璃化。培养基成分、刺激方案和实验室方案的改变也经常在没有充分验证的情况下在国际上建立。最近,为了 IVF,正在开发需要在常规临床使用前进行验证的新型设备。随着干细胞产生配子等技术的临近,在将新技术引入临床实践之前,确保进行必要的研究和开发至关重要。理想情况下,这应包括在动物模型(如小鼠/大鼠/兔子/较大的哺乳动物)上进行初步研究,然后在为研究捐赠的人类胚胎上进行研究,最后是设计良好的 RCT,并对该程序产生的所有儿童进行随访。如果没有进行和发表这些初步研究,那么可能会引入没有临床益处或导致通过这些实践出生的儿童健康结果不良的技术。所有 IVF 诊所都需要在引入新技术之前考虑其安全性和有效性。