Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial

Abstract Objective 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. Design Multicentre, open label, randomised controlled trial. Setting Four reproductive medicine centres across China. Participants 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). Interventions ICSI with genetic testing of blastocysts before transfer in the PGT-A group, and ICSI without genetic testing for the no PGT-A group. Main outcome measures 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. Results 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. Conclusion PGT-A did not improve live birth rates in ICSI for severe male infertility compared to ICSI alone, but reduced rates of pregnancy loss. Trial registration ClinicalTrials.gov NCT02941965 .