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.

Methods

Multicentre, open label, randomised controlled trial.

多中心、开放标签、随机对照试验。

Four reproductive medicine centres across China.

中国四家生殖医学中心。

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).

450对严重男性因素不育症患者计划接受ICSI治疗，被随机分配（1:1）进行PGT-A检测或不进行（每组225对夫妇）。

ICSI with genetic testing of blastocysts before transfer in the PGT-A group, and ICSI without genetic testing for the no PGT-A group.

在PGT-A组中，对囊胚进行ICSI和基因检测，而在无PGT-A组中，仅进行ICSI而不进行基因检测。

Primary outcomes were live birth after the first embryo transfer and cumulative live birth (up to three transfer cycles) within 12 months after randomisation.

主要结果是首次胚胎移植后的活产以及在随机化后12个月内最多三次移植周期内的累积活产。

Primary analysis was based on intention-to-treatprinciple.

主要分析基于意向治疗原则。

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).

在2018年7月15日至2023年1月6日期间，1347对筛查夫妇中有450对给予了知情同意，并被随机分配到干预组，即ICSI联合PGT-A（n=225）或ICSI不进行额外遗传学检测（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).

在第一次胚胎移植后，PGT-A组有109对夫妇（48.4%）和无PGT-A组有104对夫妇（46.2%）成功分娩（比值比为1.09（95%置信区间（CI）0.76至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).

每位女性的累积活产率分别为PGT-A组的60.4%（136/225）和无PGT-A组的60.9%（137/225）（比值比为0.98（95%置信区间0.67至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组在首次胚胎移植后的妊娠丢失率显著低于无PGT-A组（PGT-A组13例（5.8%）对比无PGT-A组43例（19.1%），相对风险0.26（95%置信区间0.14至0.50），P<0.001），以及累积妊娠丢失率（PGT-A组25例（11.1%）对比无PGT-A组51例（22.7%），相对风险0.43（95%置信区间0.25至0.72），P=0.001）。

Conclusions

PGT-A did not improve live birth rates in ICSI for severe male infertility compared to ICSI alone, but reduced rates of pregnancy loss.

在严重男性不育症的ICSI治疗中，PGT-A并未提高活产率，与单独使用ICSI相比，但降低了妊娠丢失率。

trial_registration

ClinicalTrials.gov NCT02941965.

ClinicalTrials.gov NCT02941965。