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Clinical Trial · English Editorial Summary

Women's Hospital, Zhejiang University: PGT-A added to ICSI in severe male factor infertility, a randomised trial

Edited by Wellward China · Sources checked 20 October 2026 · Reported 23 December 2025
ZJU Women's Hospital Hangzhou Women's Health & Fertility IVF Preimplantation genetic testing Clinical Trial
Source and editorial note: this is an original English summary written from the sources listed in the References below. It is not a full translation, and it is not an independent clinical assessment. The cited sources are the authority for the original account.

Quick answer

Patients routinely ask whether "third generation" IVF is better than "second generation". The question is not rhetorical: PGT-A adds an embryo biopsy, a week of culture to blastocyst, a fee, and in most clinics a freeze-all cycle — and it discards embryos judged aneuploid. Whether that improves the chance of a baby in couples whose infertility is due to severe male factor is what this trial tested. Huang Hefeng's team at Zhejiang University's women's hospital, across four centres, found it does not: live birth was no higher. Miscarriage, however, was lower. The trial was published in The BMJ on 23 December 2025 [1][4][6].

Key takeaways

  • Design: multicentre, open-label, randomised controlled trial at four reproductive medicine centres in China [6].
  • Population: 450 couples planning ICSI for severe male factor infertility, randomised 1:1 [6].
  • Primary outcomes: live birth after the first embryo transfer, and cumulative live birth within 12 months (up to three transfers) [6].
  • Result: no improvement in live birth; pregnancy loss reduced [4].
  • Enrolment ran from 15 July 2018 to 6 January 2023, out of 1,347 couples screened [6].

Why the question was open

Severe male factor infertility is treated with ICSI because the sperm cannot penetrate the egg unaided. The rationale for adding PGT-A is that embryos from such sperm might carry more chromosomal errors, so screening would avoid transferring them. That rationale is plausible but was never tested with live birth as the endpoint in this group — earlier evidence came largely from older women or from good-prognosis populations where the absolute benefit is small [1][3].

PGT-A versus ICSI in severe male infertility, randomised trial
PGT-A added to ICSI in severe male infertility.

The finding that miscarriage falls while live birth does not is internally consistent: PGT-A avoids transferring embryos destined to miscarry, but the embryos it removes would mostly not have implanted anyway, so the cumulative chance of a live birth across three transfers is unchanged [4].

How to use a negative trial

This is a trial that should reduce intervention rather than increase it. If PGT-A does not raise live birth in this population, its routine use adds cost and embryo attrition without benefit — and the authors and commentators frame it as a corrective to the assumption that newer technology is better technology [2][5].

Open-label, and one population

Neither patients nor clinicians were blinded, which for a technology with psychological and logistic effects is a limitation, though the primary endpoint is objective. The trial addresses severe male factor infertility specifically; it says nothing about advanced maternal age, recurrent miscarriage or recurrent implantation failure, where PGT-A may still have a role. Of 1,347 couples screened, only 450 were randomised, so the population is selected. Cost data were not the endpoint, but the economic argument follows directly from a null clinical result [3][6].

The condition in context: severe male factor infertility

Male factor contributes to roughly half of couples presenting for assisted reproduction, and ICSI bypasses the sperm's natural selection.

RegionWhat the data showsSource
Standard ICSI is the main treatment for severe male factor infertility [3]. Science and Technology Daily [3]
Technology ladder Patients commonly assume higher-generation IVF means higher success [2]. Zhejiang Daily via hospital [2]
Birth defect data Hospital follow-up data put birth defect rates at 4.82% for IVF, 5.66% for ICSI and 7.14% for PGT-A [7]. Baidu Baike summary [7]

Because PGT-A also adds a biopsy step and cryopreservation, a null result on live birth shifts the risk-benefit calculation decisively [4][5].

Why it matters

For the patientWhat the report suggestsSource
Expectation Newer is not automatically better [2][5]. [2][5]
Miscarriage Lower with PGT-A, which matters to some couples [4]. [4]
Cost Avoiding an unnecessary add-on reduces treatment cost [2]. [2]

Availability and limits

  • This is an editorial summary of the publication, not a treatment recommendation [1][6].
  • Applies to severe male factor infertility, not to all IVF [3].
  • Open-label design [6].
  • PGT-A may still be justified for other indications [5].
  • Laboratory performance of biopsy and testing varies between clinics [4].

What to ask before booking

QuestionWhy it matters
What is the specific reason PGT-A is being proposed for me? The trial does not support it for male factor alone [3].
How many embryos might be discarded, and does that change my cumulative chance? Cumulative live birth was unchanged [6].
Which department handles foreign patients, and in what language? ZJU Women's Hospital is a working hospital we do not book; confirm international-department coordination and language support.
What is the added cost and waiting time? Both are real and were not offset by benefit [2].

Questions patients ask

What was tested?

ICSI with versus without preimplantation genetic testing for aneuploidy in 450 couples with severe male factor infertility, across four Chinese centres [6].

What was the result?

Live birth after the first transfer and cumulative live birth within 12 months did not differ; pregnancy loss was lower with PGT-A [4].

Who led it?

Huang Hefeng, of Zhejiang University's reproductive genetics key laboratory and honorary president of its women's hospital [2][5].

Where was it published?

The BMJ, online 23 December 2025 [1][4].

Is this relevant to international patients?

It is useful context for IVF decision-making in China. The hospital is a working hospital we do not book — contact its international department directly [1].