Efficacy of preimplantation genetic testing for aneuploidy in improving pregnancy outcome among couples with azoospermia: study protocol for a multicenter, randomized controlled trial.
7 affiliations
- 1Department of Reproductive Medicine, Shanghai Key Laboratory for Assisted Reproduction and Reproductive Genetics, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
- 2State Key Laboratory of Reproductive Medicine and Offspring Health, Centre for Reproductive Medicine, Institute of Women, Children and Reproductive Health, Shandong University, Jinan, China.
- 3National Research Centre for Assisted Reproductive Technology and Reproductive Genetics, Shandong University, Jinan, China.
- 4Key Laboratory of Reproductive Endocrinology, Ministry of Education, Shandong University, Jinan, China.
- 5Research Unit of Gametogenesis and Health of ART-Offspring, Chinese Academy of Medical Sciences (No 2021RU001), Jinan, China.
- 6Centre for Reproductive Medicine, Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, Shenyang, China.
- 7Shanghai Immune Therapy Institute, Shanghai Jiao Tong University School of Medicine-Affiliated Renji Hospital, Shanghai, China.
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.
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BibTeX
@article{he2026efficacy,
title = {{Efficacy of preimplantation genetic testing for aneuploidy in improving pregnancy outcome among couples with azoospermia: study protocol for a multicenter, randomized controlled trial.}},
author = {Yaqiong He and Jiaan Huang and Junhao Yan and Jichun Tan and Zhe Wei and Yun Sun and Yao Lu},
journal = {Frontiers in endocrinology},
year = {2026},
month = oct,
doi = {10.3389/fendo.2026.1903245},
url = {https://europepmc.org/article/MED/42908544},
note = {CC BY},
}
RIS
TY - JOUR
TI - Efficacy of preimplantation genetic testing for aneuploidy in improving pregnancy outcome among couples with azoospermia: study protocol for a multicenter, randomized controlled trial.
AU - Yaqiong He
AU - Jiaan Huang
AU - Junhao Yan
AU - Jichun Tan
AU - Zhe Wei
AU - Yun Sun
AU - Yao Lu
PY - 2026
DA - 2026/10/07
JO - Frontiers in endocrinology
DO - 10.3389/fendo.2026.1903245
UR - https://europepmc.org/article/MED/42908544
AB - 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.
SN - 1664-2392
ER -