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

Jin Huang, Li Rong, Lin Zeng, Liang Hu, Juanzi Shi, Liyi Cai, Bing Yao, Xiu-Xia Wang, Yanwen Xu, Yuanqing Yao, Yan Wang, Junzhao Zhao, Yichun Guan, Weiping Qian, Guimin Hao, Sijia Lu, Ping Liu, Jie Qiao, Jin Huang, Li Rong, Lin Zeng, Liang Hu, Juanzi Shi, Liyi Cai, Bing Yao, Xiu-Xia Wang, Yanwen Xu, Yuanqing Yao, Yan Wang, Junzhao Zhao, Yichun Guan, Weiping Qian, Guimin Hao, Sijia Lu, Ping Liu, Jie Qiao

Abstract

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.

Keywords: antenatal; embryology; prenatal diagnosis.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flowchart of this randomised controlled trial. NICS, non-invasive chromosome screening; ni-PGT, non-invasive preimplantation genetic testing.

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