Efficacy of preimplantation genetic testing for aneuploidy in improving pregnancy outcome among couples with azoospermia: study protocol for a multicenter, randomized controlled trial.

Abstract

Background: Azoospermia affects up to one in ten infertile couples and represents one of the most challenging conditions in male infertility. Although the development of intracytoplasmic sperm injection (ICSI) enables azoospermic men to achieve biological parenthood, overall success rates remain modest. Preimplantation genetic testing for aneuploidy (PGT-A) is increasingly promoted and used worldwide to improve pregnancy outcomes and enhance the efficiency of ICSI; however, its efficacy for couples with azoospermia remains uncertain. Robust evidence from adequately powered randomized controlled trials (RCTs) is still lacking to determine whether PGT-A can increase the live birth rate as the primary outcome in this context.

Methods: This trial is designed as a prospective, multicenter, open-label RCT. Couples with azoospermia (female age 20-37 years; male age 20-55 years) who intend to undergo ICSI with partner's sperm will be screened for eligibility. Women who have at least two blastocysts available on day 5 of embryo culture will be enrolled and randomly assigned in a 1:1 ratio to receive either PGT-A or conventional ICSI. A freeze-all strategy with single frozen-thawed blastocyst transfer will be implemented in both groups. The primary outcome is live birth rate.

Discussion: The findings of this trial are expected to provide high-quality evidence regarding the efficacy of PGT-A for couples with azoospermia, helping optimize individualized patient management and improve overall treatment efficiency.

Clinical trial registration: http://www.chictr.org.cn/, identifier ChiCTR2100043421.