Infertility Unit, ASST Lariana, Cantù, Italy.
First Unit of Obstetrics and Gynecology, Department of Interdisciplinary Medicine, University of Bari, Bari, Italy.
J Transl Med. 2024 Jul 28;22(1):687. doi: 10.1186/s12967-024-05515-x.
In assisted reproductive technology (ART), the choice between intracytoplasmic sperm injection (ICSI) and conventional in vitro insemination (IVF) remains a pivotal decision for couples with female or unexplained infertility. The hypothesis that ICSI may not confer significant improvements in live birth rates in the absence of a male infertility factor was explored in this study.
This was a retrospective collection of data recorded by the Human Fertilisation and Embryology Authority (HFEA) in the UK from 2005 to 2018 and analysed through regression analysis models on both the entire dataset and a matched-pair subset. First fresh ART cycles were analysed according to the insemination technique in order to compare live birth as the main outcome. Cycles were included if complete information regarding infertility cause, female age, number of oocytes retrieved, allocation to ICSI or IVF, and treatment outcome in terms of live birth was available. Matching was performed at a 1:1 ratio between IVF and ICSI cycles according to the cause of infertility, female age, number of oocytes, and year of treatment.
This study, based on 275,825 first cycles, revealed that, compared with IVF, ICSI was associated with higher fertilization rates and lower cycle cancellations rates. However, ICSI was associated with a lower chance of implantation and live birth than IVF in cycles with female-only infertility: in the entire dataset, the adjusted odds of having a live birth decreased by a factor of 0.95 (95% CI 0.91-0.99, p = 0.011), while in the matched-pair analyses it decreased by a factor of 0.91 (95% CI 0.86-0.96, p = 0.003) using ICSI compared to IVF. For unexplained infertility cycles, the adjusted odds ratios for live birth in ICSI compared to IVF cycles were 0.98 (95% CI 0.95-1.01) in the entire dataset and 0.97 (95% CI 0.93-1.01) in the matched-pair analysis.
Compared with IVF, ICSI was associated with a reduction in live births when ART was indicated due to female-only factors. Additionally, no significant improvements were associated with the use of ICSI in cycles with unexplained infertility. Our findings impose a critical reevaluation regarding the use of ICSI over IVF for cases with female-only factors and unexplained infertility.
在辅助生殖技术（ART）中，对于患有女性因素或不明原因不孕的夫妇，选择胞浆内单精子注射（ICSI）还是常规体外受精（IVF）仍然是一个关键决策。本研究旨在探讨在不存在男性不育因素的情况下，ICSI 是否可能不会显著提高活产率的假设。
这是英国人类受精与胚胎管理局（HFEA） 2005 年至 2018 年期间收集的数据的回顾性分析，并通过回归分析模型对整个数据集和匹配对亚组进行了分析。首先，根据授精技术对新鲜的 ART 周期进行分析，以比较活产率作为主要结局。如果有完整的不孕原因、女性年龄、卵母细胞数量、ICSI 或 IVF 分配以及活产治疗结局的信息，则纳入周期。根据不孕原因、女性年龄、卵母细胞数量和治疗年份，以 1:1 的比例在 IVF 和 ICSI 周期之间进行匹配。
这项基于 275825 个首次周期的研究表明，与 IVF 相比，ICSI 与更高的受精率和更低的周期取消率相关。然而，在仅女性不孕的周期中，ICSI 与植入和活产的机会低于 IVF：在整个数据集，调整后的活产几率降低了 0.95 倍（95%CI 0.91-0.99，p=0.011），而在匹配对分析中，ICSI 与 IVF 相比降低了 0.91 倍（95%CI 0.86-0.96，p=0.003）。对于不明原因不孕的周期，在整个数据集，ICSI 与 IVF 相比，活产的调整优势比为 0.98（95%CI 0.95-1.01），在匹配对分析中为 0.97（95%CI 0.93-1.01）。
与 IVF 相比，当 ART 因仅女性因素而指征时，ICSI 与活产率降低相关。此外，在不明原因不孕的周期中，使用 ICSI 与活产率没有显著提高相关。我们的研究结果对仅女性因素和不明原因不孕的病例中使用 ICSI 替代 IVF 提出了严格的重新评估。
