RT Journal Article
SR Electronic
T1 Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e057254
DO 10.1136/bmjopen-2021-057254
VO 12
IS 7
A1 Jin Huang
A1 Rong Li
A1 Lin Zeng
A1 Liang Hu
A1 Juanzi Shi
A1 Liyi Cai
A1 Bing Yao
A1 Xiu-Xia Wang
A1 Yanwen Xu
A1 Yuanqing Yao
A1 Yan Wang
A1 Junzhao Zhao
A1 Yichun Guan
A1 Weiping Qian
A1 Guimin Hao
A1 Sijia Lu
A1 Ping Liu
A1 Jie Qiao
YR 2022
UL http://bmjopen.bmj.com/content/12/7/e057254.abstract
AB Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT04339166.