To assess the efficacy of preimplantation genetic testing for aneuploidies (PGT-A) compared to intracytoplasmic sperm injection (ICSI) alone in couples undergoing ICSI treatment because of severe male infertility.
Multicentre, open label, randomised controlled trial.
Four reproductive medicine centres across China.
450 couples with severe male factor infertility scheduled for ICSI were randomly assigned (1:1) to undergo PGT-A or not (225 couples in each group).
ICSI with genetic testing of blastocysts before transfer in the PGT-A group, and ICSI without genetic testing for the no PGT-A group.
Primary outcomes were live birth after the first embryo transfer and cumulative live birth (up to three transfer cycles) within 12 months after randomisation. Primary analysis was based on intention-to-treat principle.
Between 15 July 2018 and 6 January 2023, 450 of 1347 screened couples gave informed consent and were randomised to the intervention, ICSI with PGT-A (n=225), or ICSI with no additional genetic testing (n=225). In total, 109 couples in the PGT-A group (48.4%) and 104 couples in the no PGT-A group (46.2%) had a live birth after the first embryo transfer (odds ratio 1.09 (95% confidence interval (CI) 0.76 to 1.58), P=0.64). The cumulative live birth rates per woman were 60.4% (136/225) and 60.9% (137/225) in the PGT-A and no PGT-A groups, respectively (0.98 (0.67 to 1.43), P=0.92). The PGT-A group had significantly lower rates of pregnancy loss after the first embryo transfer (13 (5.8%) PGT-A group v 43 (19.1%) no PGT-A group, 0.26 (0.14 to 0.50), P<0.001) and cumulative pregnancy loss (25 (11.1%) v 51 (22.7%), 0.43 (0.25 to 0.72), P=0.001) than the no PGT-A group.
PGT-A did not improve live birth rates in ICSI for severe male infertility compared to ICSI alone, but reduced rates of pregnancy loss.
ClinicalTrials.gov NCT02941965.
BMJ (Clinical research ed.). 2025 Dec 23*** epublish ***
Xianhua Lin, Dandan Wu, Chen Zhang, Lulu Wang, Yao Lu, Ping Zhou, Chengliang Zhou, Li Jin, Li Wang, Hong Zhu, Jiexue Pan, Chenming Xu, Songchang Chen, Ling Gao, Lu Li, Songying Zhang, Yanting Wu, Yun Sun, Ben W Mol, Hefeng Huang
Department of Reproductive Endocrinology, Key Laboratory of Reproductive Genetics (Ministry of Education), Women's Hospital, Institute of Medical Genetics and Development, Zhejiang University School of Medicine, Hangzhou 311500, China., Department of Reproductive Medicine, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University, Shanghai, China., Institute of Reproduction and Development, Obstetrics and Gynaecology Hospital, Fudan University, Shanghai, China., Department of Reproductive Medicine, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China., Department of Obstetrics and Gynaecology, Assisted Reproduction Unit, Sir Run Run Hospital, School of Medicine, Zhejiang University, Hangzhou, China., Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia., Department of Reproductive Endocrinology, Key Laboratory of Reproductive Genetics (Ministry of Education), Women's Hospital, Institute of Medical Genetics and Development, Zhejiang University School of Medicine, Hangzhou 311500, China .