Centre for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.
National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.
BMJ Open. 2022 Jul 27;12(7):e057254. doi: 10.1136/bmjopen-2021-057254.
Morphological evaluation is used to select embryos for in vitro fertilisation. However, it does not fully reflect the implantation potential. Preimplantation genetic testing for aneuploidies (PGT-A) can detect embryonic aneuploidy, but biopsy procedure is invasive. Currently, a non-invasive PGT (ni-PGT) approach using spent medium is being evaluated. However, the clinical benefit of ni-PGT has not been clearly demonstrated. A multicentre randomised trial is needed to verify whether ni-PGT can be an new effective tool for evaluating embryos.
Overall, 1148 couples aged 35~42 (women) receiving in vitro fertilization-intracytoplasmic sperm injection are planned to be enrolled. Couples will be digitally randomised to (1) ni-PGT and (2) conventional morphology groups at a 1:1 treatment ratio. The primary outcome will be the ongoing pregnancy rate related to the first transfer cycle within 6 months after oocyte retrieval.
The study protocol is approved by the Ethics Committee of Peking University Third Hospital and the participating hospitals. The results will be disseminated through international conferences and scientific journals.
NCT04339166.
形态学评估用于选择体外受精胚胎。然而，它并不能完全反映胚胎的着床潜能。胚胎植入前遗传学检测（PGT-A）可以检测胚胎的非整倍体，但活检过程具有侵袭性。目前，正在评估一种使用废弃培养液的非侵入性 PGT（ni-PGT）方法。然而，ni-PGT 的临床获益尚未得到明确证实。需要开展多中心随机试验来验证 ni-PGT 是否可以成为评估胚胎的一种新的有效工具。
总共计划纳入 1148 对年龄在 35~42 岁（女性）接受体外受精-胞浆内单精子注射的夫妇。夫妇将以 1:1 的治疗比例进行数字随机分组，分别进入（1）ni-PGT 组和（2）传统形态学组。主要结局为取卵后 6 个月内首次移植周期的持续妊娠率。
该研究方案已获得北京大学第三医院伦理委员会和参与医院的批准。研究结果将通过国际会议和科学期刊进行传播。
NCT04339166。
