Beebeejaun Yusuf, Nicolaides Kypros H, Mania Anastasia, Sarris Ippokratis, Sunkara Sesh K
King's Fertility, Fetal Medicine Research Institute, King's College Hospital, London SE5 8BB, UK.
Department of Women's and Children's Health, Faculty of Life Sciences and Medicine, King's College London, London SE1 7EH, UK.
J Clin Med. 2024 Oct 17;13(20):6192. doi: 10.3390/jcm13206192.
: Poor outcomes following IVF treatments are speculated to be due to the transfer of aneuploid embryos that cannot be identified based on morphological evaluation alone. This leads to patients requiring numerous embryo transfers and, consequently, a prolonged time interval before live birth. Embryo selection following preimplantation genetic testing for aneuploidy (PGT-A) with next-generation sequencing (NGS) has been suggested as an intervention to shorten time to pregnancy in women undergoing in vitro fertilisation (IVF). Past studies assessing the clinical efficacy of PGT-A in improving clinical outcomes have been conflicting and the associated clinical pregnancy rates and live birth rates following the transfer of a mosaic embryos have yet to be determined. None of the existing studies solely included women of advanced reproductive age (ARA). The pilot study and proposed RCT will determine if, compared to morphological evaluation alone, the use of PGT-A through NGS is a more clinically effective, safer, and more cost-effective way to provide IVF treatment in women of advanced reproductive age. : The proposed pilot study will aim to randomise 100 patients within a single-centre study to evaluate recruitment, randomisation, and adherence to study protocol and allocated trail arms by participating patients. The results of the pilot study will enable us to determine the sample size for a larger study to establish the effectiveness of PGT-A in ARA women. : The study (Integrated Research Application System Number 236067) received approval from the Health Research Authority and Health and Care Research Wales (HCRW) and the East Midlands-Leicester South Research Ethics Committee (20/EM/0290). The results will be made available to patients, the funders, the Reproductive Medicine societies, and other researchers. : ClinicalTrials.gov Identifier: NCT05009745, n.
体外受精（IVF）治疗后出现不良结局，据推测是由于非整倍体胚胎的移植，而仅通过形态学评估无法识别这些胚胎。这导致患者需要进行多次胚胎移植，从而延长了活产之前的时间间隔。有人提出，采用下一代测序（NGS）进行植入前非整倍体基因检测（PGT-A）后进行胚胎选择，作为一种干预措施，可缩短接受体外受精（IVF）女性的怀孕时间。过去评估PGT-A改善临床结局临床疗效的研究结果相互矛盾，镶嵌胚胎移植后的相关临床妊娠率和活产率尚未确定。现有的研究均未单独纳入高龄育龄（ARA）女性。这项初步研究和拟议的随机对照试验将确定，与单纯形态学评估相比，通过NGS使用PGT-A是否是为高龄育龄女性提供IVF治疗更具临床效果、更安全且更具成本效益的方法。：拟议的初步研究旨在在单中心研究中对100名患者进行随机分组，以评估招募、随机分组情况以及参与患者对研究方案和分配的试验组的依从性。初步研究结果将使我们能够确定更大规模研究的样本量，以确定PGT-A在ARA女性中的有效性。：该研究（综合研究应用系统编号236067）获得了健康研究管理局、威尔士卫生与护理研究（HCRW）以及东米德兰兹-莱斯特南部研究伦理委员会（20/EM/029） 的批准。研究结果将提供给患者、资助者、生殖医学协会以及其他研究人员。：ClinicalTrials.gov标识符：NCT-05009745，编号。
