Study question Does Intracytoplasmic Sperm Injection (ICSI) improve reproductive outcomes in patients with non-male factor infertility undergoing Frozen-Thawed Embryo Transfer (FET) treatment? Summary answer ICSI showed slightly improved clinical outcomes compared to IVF, but was associated with higher preterm birth rates and low birthweight when twins were born. What is known already The use of ICSI has seen a significant surge globally, particularly in Europe and the USA, as a solution for fertilization failure resulting from male factor infertility. FET presents a viable option for those considering additional children. Numerous studies have investigated the effectiveness of ICSI in couples with non-male factor infertility undergoing fresh embryo transfer in ovarian stimulation cycles. However, there is a dearth of evidence demonstrating whether ICSI, compared to conventional IVF (cIVF), could influence reproductive outcomes in couples with non-male factor infertility undergoing FET treatment. Study design, size, duration This retrospective cohort study included 10,143 cycles from 6,206 couples who underwent FET at the Third Affiliated Hospital of Zhengzhou University between January 2016 and September 2022. Participants/materials, setting, methods Patients were categorized into two groups based on the insemination methods used for the transferred embryos. Patients were excluded if : 1) Embryos were biopsied and tested; 2) Oocytes had been vitrified; 3) Embryos were derived from donor oocytes, AOA treatment, or rescue ICSI; 4) Embryos that were not transferred; and 5) They had undergone fresh embryo transfer. PSM at a ratio of 1:1 was utilized to ensure comparability of reproductive outcomes. Main results and the role of chance Post-PSM, the general characteristics were comparable across both groups. The clinical pregnancy rates (37.6% vs 40.0%, P = 0.311), miscarriage rates (21.4% vs 23.1%, P = 0.597), and live birth rates (28.2% vs 30.4%, P = 0.329) exhibited no significant disparity post-PSM between the two groups. Notably, a marginally elevated live birth rate was observed in the ICSI group when blastocysts were transferred to the women (39.8% vs 48.3%, P = 0.050). However, the GEE models indicated that ICSI did not enhance the likelihood of clinical pregnancy, miscarriage, and live birth relative to IVF in women with non-male factor infertility. Following adjustments for variables, ICSI yielded consistent OR values [1.14(0.92-1.42), P = 0.241; 1.08(0.72-1.61), P = 0.703; and 1.16(0.92-1.46), P = 0.220, respectively]. The perinatal outcomes were similar between the two grousps. However, a significantly higher incidence of preterm birth was observed in the ICSI group compared to the cIVF group (20.0% vs 12.5%, P = 0.026). While pregnancy complications were comparable between the two groups, neonates born as twins in the ICSI group exhibited significantly reduced live birth-weight [2520.8(572.9) vs 2691.9(423.7), P = 0.043] and birth length [47.5(2.8) vs 48.5(2.3), P = 0.031]. Correspondingly, the rate of low birthweight was significantly higher in the ICSI group (38.9% vs 21.0%, P = 0.025). Limitations, reasons for caution The retrospective design may lead to selection bias among the included patients. The use of ICSI in ART has been strictly regulated in our country, limiting the sample size and potentially reducing the statistical power. Wider implications of the findings The value of ICSI should be thoroughly discussed with patients with non-male factor infertility before ovarian stimulation. Further research is needed to better understand the impact of ICSI on reproductive and neonatal outcomes in this population. Trial registration number 2021YFC2700602

中文翻译：

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P-126 ICSI 与 IVF 对非男性因素不孕夫妇生殖结果和冻融胚胎移植周期的影响


研究问题 胞浆内单精子注射 (ICSI) 能否改善接受冻融胚胎移植 (FET) 治疗的非男性因素不育患者的生殖结局？摘要答案 ICSI 与 IVF 相比，临床结果略有改善，但与双胞胎出生时较高的早产率和低出生体重有关。已知情况 ICSI 的使用在全球范围内显着激增，特别是在欧洲和美国，作为男性因素不育导致的受精失败的解决方案。 FET 为那些考虑生育孩子的人提供了一个可行的选择。大量研究调查了 ICSI 对于非男性因素不孕夫妇在卵巢刺激周期中接受新鲜胚胎移植的有效性。然而，缺乏证据表明，与传统 IVF (cIVF) 相比，ICSI 是否会影响接受 FET 治疗的非男性因素不孕夫妇的生殖结果。研究设计、规模、持续时间 这项回顾性队列研究纳入了 2016 年 1 月至 2022 年 9 月期间在郑州大学第三附属医院接受 FET 的 6,206 对夫妇的 10,143 个周期。 参与者/材料、设置、方法 根据患者的情况将患者分为两组用于移植胚胎的授精方法。如果出现以下情况，患者将被排除： 1) 对胚胎进行活检和测试； 2) 卵母细胞已玻璃化冷冻； 3) 胚胎来源于供体卵母细胞、AOA治疗或救援ICSI； 4）未移植的胚胎； 5) 他们接受了新鲜胚胎移植。采用 1:1 比例的 PSM 以确保生殖结果的可比性。 主要结果和机会的作用 PSM 后，两组的一般特征具有可比性。临床妊娠率（37.6% vs 40.0%，P = 0.311）、流产率（21.4% vs 23.1%，P = 0.597）和活产率（28.2% vs 30.4%，P = 0.329）在术后没有显着差异。 -两组之间的PSM。值得注意的是，当囊胚移植到女性体内时，ICSI 组的活产率略有升高（39.8% vs 48.3%，P = 0.050）。然而，GEE 模型表明，与 IVF 相比，ICSI 并未提高非男性因素不孕女性临床妊娠、流产和活产的可能性。对变量进行调整后，ICSI 产生一致的 OR 值 [1.14(0.92-1.42)，P = 0.241； 1.08（0.72-1.61），P=0.703；和1.16（0.92-1.46），P = 0.220，分别]。两组的围产期结局相似。然而，与 cIVF 组相比，ICSI 组的早产发生率显着较高（20.0% vs 12.5%，P = 0.026）。虽然两组之间的妊娠并发症相当，但 ICSI 组中双胞胎出生的新生儿的活产体重 [2520.8(572.9) vs 2691.9(423.7)，P = 0.043] 和出生身长 [47.5(2.8) vs 48.5] 显着降低。 （2.3），P = 0.031]。相应地，ICSI组的低出生体重率显着较高（38.9% vs 21.0%，P = 0.025）。局限性、谨慎原因回顾性设计可能会导致纳入患者中的选择偏倚。在我国，ART 中 ICSI 的使用受到严格监管，限制了样本量，并可能降低统计功效。 研究结果的更广泛影响 在卵巢刺激之前，应与非男性因素不孕患者彻底讨论 ICSI 的价值。需要进一步的研究来更好地了解 ICSI 对这一人群生殖和新生儿结局的影响。 试用注册号2021YFC2700602