Objective

To compare the cumulative live birth rates (CLBRs) and cost effectiveness of intracytoplasmic sperm injection (ICSI) and conventional in vitro fertilization (cIVF) for non-male factor infertility.

Design

A retrospective cohort study.

Setting

Society for Assisted Reproductive Technology clinics.

Patient(s)

A total of 46,967 patients with non-male factor infertility with the first autologous oocyte retrieval cycle between January 2014 and December 2015.

Intervention(s)

None.

Main Outcome Measure(s)

The primary outcomes were CLBR, defined as up to 1 live birth from an autologous retrieval cycle between 2014 and 2015, and linked fresh and frozen embryo transfers through 2016. The secondary outcomes included miscarriage rate, 2 pronuclei per oocyte retrieved, and the total number of transferred and frozen embryos. Analyses were performed on subsamples with and without preimplantation genetic testing for aneuploidy (PGT-A). A cost analysis was performed to determine the costs accrued by ICSI.

Result(s)

Among cycles without PGT-A in patients with non-male factor infertility, the CLBR was 60.9% for ICSI cycles vs. 64.3% for cIVF cycles, a difference that was not significantly different after adjustment for covariates (adjusted risk ratio, 0.99; 95% confidence interval, 0.99–1.00). With PGT-A, no difference in CLBR was found between ICSI and cIVF cases after adjustment (64.7% vs. 69.0%, respectively; adjusted risk ratio, 0.97; 95% confidence interval, 0.93–1.01). The patients were charged an estimated additional amount of $37,476,000 for ICSI without genetic testing and an additional amount of $7,213,500 for ICSI with PGT-A over 2 years by Society for Assisted Reproductive Technology clinics.

Conclusion(s)

In patients with non-male factor infertility, ICSI did not improve CLBR. Given the additional cost and the lack of CLBR benefit, our data show that the routine use of ICSI in patients with non-male factor infertility is not warranted.

中文翻译：

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非男性因素不育患者胞浆内单精子注射与传统体外受精的比较

 客观的

比较胞浆内单精子注射 (ICSI) 和传统体外受精 (cIVF) 治疗非男性因素不孕症的累积活产率 (CLBR) 和成本效益。

 设计

一项回顾性队列研究。

 环境

辅助生殖技术诊所协会。

 患者）

2014年1月至2015年12月期间，共有46,967名非男性因素不孕患者接受了第一个自体卵母细胞取出周期。

 干预措施

 没有任何。

 主要观察指标）

主要结果是 CLBR，定义为 2014 年至 2015 年间自体取出周期中最多 1 例活产，并将截至 2016 年的新鲜和冷冻胚胎移植联系起来。次要结果包括流产率、每个取出卵母细胞 2 个原核以及总数移植和冷冻胚胎。对经过和不经过非整倍性植入前基因检测 (PGT-A) 的子样本进行分析。进行成本分析以确定 ICSI 产生的成本。

 结果）

在非男性因素不孕患者的不进行 PGT-A 的周期中，ICSI 周期的 CLBR 为 60.9%，而 cIVF 周期为 64.3%，调整协变量后没有显着差异（调整后的风险比为 0.99；95） % 置信区间，0.99–1.00）。对于 PGT-A，调整后 ICSI 和 cIVF 病例之间的 CLBR 没有发现差异（分别为 64.7% 和 69.0%；调整后的风险比，0.97；95% 置信区间，0.93-1.01）。辅助生殖技术协会诊所在 2 年内对不带基因检测的 ICSI 向患者收取的额外费用估计为 37,476,000 美元，对于带有 PGT-A 的 ICSI 的患者额外收取了 7,213,500 美元的费用。

 结论

在非男性因素不育患者中，ICSI 并未改善 CLBR。考虑到额外的成本和缺乏 CLBR 益处，我们的数据表明，对于非男性因素不孕患者常规使用 ICSI 是没有必要的。