The First Clinical Medical College, Lanzhou University, Lanzhou, China.
The First Hospital of Lanzhou University, Lanzhou, China.
Acta Obstet Gynecol Scand. 2024 Jan;103(1):30-41. doi: 10.1111/aogs.14698. Epub 2023 Nov 6.
The use of intracytoplasmic sperm injection (ICSI) has dramatically increased in patients with non-male factor infertility during the last decades. However, whether ICSI provides a significant benefit over in vitro fertilization (IVF) in these patients is still controversial. In this study, we aimed to investigate the efficacy of ICSI on reproductive outcomes with non-male factor infertility and to provide updated evidence for clinical practice.
We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to March 2023. Randomized controlled trials (RCTs) comparing the efficacy between ICSI and IVF in patients with non-male factor infertility were included. The main outcomes were the live birth rate (LBR), fertilization rate (FR), and total fertilization failure (TFF). The pooled estimates were calculated using the random-effects models as relative risk (RR) with 95% confidence intervals (CIs). This systematic review and meta-analysis was registered in PROSPERO (CRD42023427004).
We included 18 RCTs with 3249 cycles and 30 994 oocytes. The results demonstrated that ICSI reduced the risk of TFF (RR = 0.26, 95% CI: 0.13-0.50, I = 58%) and increased FR per oocyte inseminated/injected (RR = 1.14, 95% CI: 1.08-1.20, I = 69%), but it did not improve LBR (RR = 1.11, 95% CI: 0.94-1.30, I = 0%) or other outcomes compared with IVF. However, the difference in fertilization failure reduction between ICSI and IVF may be explained by different randomization methods (randomization based on patients vs. sibling oocytes). When considering only studies with randomization based on patients, we found no evidence of the difference between the groups (RR = 0.72, 95% CI: 0.48-1.06, I = 0%). Furthermore, no differences were observed in subgroup analyses based on other factors, including female age, study period, and controlled ovarian stimulation protocols.
Our findings suggest that ICSI leads to no difference in reproductive outcomes compared to IVF in patients with non-male factor infertility. Considering the cost and safety of ICSI, we have no evidence to support the routine use of ICSI in these populations. High-quality RCTs with large sample sizes will be needed to confirm our results and explore clinical and neonatal outcomes.
在过去的几十年中，非男性因素不孕患者中使用胞浆内精子注射（ICSI）的数量显著增加。然而，ICSI 是否为这些患者提供了比体外受精（IVF）更显著的益处仍存在争议。在这项研究中，我们旨在研究 ICSI 对非男性因素不孕患者的生殖结局的疗效，并为临床实践提供最新证据。
我们检索了 Medline、Embase 和 Cochrane 对照试验中心注册库，检索时间从建库至 2023 年 3 月。纳入比较非男性因素不孕患者中 ICSI 和 IVF 疗效的随机对照试验（RCT）。主要结局是活产率（LBR）、受精率（FR）和总受精失败率（TFF）。使用随机效应模型计算汇总估计值，作为相对风险（RR）和 95%置信区间（CI）。本系统评价和荟萃分析已在 PROSPERO（CRD42023427004）注册。
我们纳入了 18 项 RCT，共 3249 个周期和 30994 个卵母细胞。结果表明，ICSI 降低了 TFF 的风险（RR=0.26，95%CI：0.13-0.50，I²=58%），并增加了每枚卵母细胞受精/注射的 FR（RR=1.14，95%CI：1.08-1.20，I²=69%），但与 IVF 相比，LBR（RR=1.11，95%CI：0.94-1.30，I²=0%）或其他结局并无改善。然而，ICSI 和 IVF 之间在受精失败减少方面的差异可能归因于不同的随机分组方法（基于患者的随机分组与基于姐妹卵母细胞的随机分组）。当仅考虑基于患者的随机分组的研究时，我们发现两组之间没有差异的证据（RR=0.72，95%CI：0.48-1.06，I²=0%）。此外，基于其他因素（包括女性年龄、研究期间和控制性卵巢刺激方案）的亚组分析也未观察到差异。
我们的研究结果表明，与 IVF 相比，ICSI 并未对非男性因素不孕患者的生殖结局产生差异。考虑到 ICSI 的成本和安全性，我们没有证据支持在这些人群中常规使用 ICSI。需要高质量、大样本量的 RCT 来证实我们的结果，并探讨临床和新生儿结局。
