STUDY QUESTION Does the use of frozen sperm affect live birth rate (LBR) and cumulative LBR (CLBR) compared to fresh sperm samples in oocyte donation ICSI cycles? SUMMARY ANSWER Although there were slight decreases in pregnancy rates (PRs) and LBR, as well as CLBR per embryo replaced and per embryo transfer (ET), when frozen sperm samples were used compared to fresh ejaculates, their clinical impact was limited. WHAT IS KNOWN ALREADY Sperm cryopreservation is part of the daily routine in reproduction clinics worldwide because of its many advantages in cycle planning. Nonetheless, there is a lack of agreement in terms of its impact on the outcomes of ICSI cycles. Previous studies showed conflicting conclusions and focused on different populations, which makes reaching consensus on the impact of sperm freezing-thawing complicated. Moreover, classical parameters are used to assess cycle success: pregnancy, live birth and miscarriage rates per ET. This study reports those measurements plus CLBR, which more accurately reflects the impact of the technique on the likelihood of achieving a newborn. STUDY DESIGN, SIZE, DURATION A retrospective multicenter observational cohort study, including data from 37 041 couples and 44 423 ICSI procedures from January 2008 to June 2022, was carried out. The group using frozen sperm included 23 852 transferred embryos and 108 661 inseminated oocytes, whereas the fresh sample group comprised 73 953 embryos replaced and 381 509 injected oocytes. PARTICIPANTS/MATERIALS, SETTING, METHODS Outcomes measured per first ET and per ET were compared between groups using Fisher’s exact test and Chi-squared test, as appropriate. Binary-logistics regression models were used to adjust the analyses according to clinically relevant co-variables. Kaplan–Meier curves plotted the CLBR per oocyte inseminated, per embryo replaced and per ET, and compared between groups using the Mantel–Cox test. Cox regressions were employed for the multivariate analyses of CLBR. MAIN RESULTS AND THE ROLE OF CHANCE The frozen sperm group showed a slightly lower biochemical (3.55% and 2.56%), clinical (3.68% and 3.54%) and ongoing (3.63% and 3.15%) PR compared to the cycles using fresh sperm, respectively, both per first ET and per ET. LBR was 4.57% lower per first ET and 3.95% lower per ET in the frozen sperm group than the fresh sperm group. There was also a subtle increase of 2.66% in biochemical miscarriage rate per ET when using frozen versus fresh sperm. All these differences remained statistically significant after the multivariate analysis (adjusted P ≤ 0.001). There were statistically significant differences in CLBR per embryo replaced and per ET but not per oocyte used (adjusted P = 0.071). Despite the statistical significance of the differences between the groups, those using frozen sperm required only 0.54 more oocytes injected, 0.45 more embryos transferred and 0.41 more ET procedures, on average, to achieve a live birth compared to the fresh samples. LIMITATIONS, REASONS FOR CAUTION The retrospective nature of the study subjects the data to biases or potential errors during annotation on the source clinical and cycle records. This study uses multivariate analyses to control biases as much as possible. Using the oocyte donation model also contributes to reducing heterogeneity in the oocyte quality factor. WIDER IMPLICATIONS OF THE FINDINGS The large sample sizes included in this study allowed for the detection of small changes in cycle success rates between groups. Although statistically significant, the decrease in PRs, LBR, and CLBR when using frozen sperm can be clinically overlooked in favor of the many benefits of sperm cryopreservation. STUDY FUNDING/COMPETING INTEREST(S) None declared. TRIAL REGISTRATION NUMBER Not applicable

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新鲜与冷冻保存的射精精子样本的生殖结果评估——对 44 423 个卵母细胞捐赠 ICSI 周期的回顾性分析

研究问题 与卵母细胞捐赠 ICSI 周期中的新鲜精子样本相比，使用冷冻精子是否会影响活产率 (LBR) 和累积 LBR (CLBR)？摘要：尽管与新鲜精液相比，使用冷冻精子样本时，妊娠率 (PR) 和 LBR 以及每次更换胚胎和每次胚胎移植 (ET) 的 CLBR 略有下降，但其临床影响有限。已知的情况 精子冷冻保存因其在周期规划方面的许多优势而成为全世界生殖诊所日常工作的一部分。尽管如此，对于其对 ICSI 周期结果的影响仍缺乏共识。之前的研究得出的结论相互矛盾，并且关注的人群不同，这使得就精子冻融的影响达成共识变得复杂。此外，经典参数用于评估周期成功：每个 ET 的妊娠率、活产率和流产率。这项研究报告了这些测量值加上 CLBR，这更准确地反映了该技术对新生儿可能性的影响。研究设计、规模、持续时间进行了一项回顾性多中心观察队列研究，包括 2008 年 1 月至 2022 年 6 月期间 37 041 对夫妇和 44 423 例 ICSI 手术的数据。使用冷冻精子的组包括 23 852 个移植胚胎和 108 661 个受精卵母细胞，而新鲜样本组包括 73 953 个替换胚胎和 381 509 个注射卵母细胞。参与者/材料、环境、方法 根据情况，使用 Fisher 精确检验和卡方检验对每次 ET 测量的结果和每次 ET 测量的结果进行比较。使用二元逻辑回归模型根据临床相关协变量调整分析。 Kaplan-Meier 曲线绘制了每个受精卵母细胞、每个替换胚胎和每个 ET 的 CLBR，并使用 Mantel-Cox 检验进行组间比较。 Cox 回归用于 CLBR 的多变量分析。主要结果和机会的作用 与使用新鲜精子的周期相比，冷冻精子组的生化（3.55% 和 2.56%）、临床（3.68% 和 3.54%）以及持续（3.63% 和 3.15%）PR 略低。分别为每个第一个 ET 和每个 ET。与新鲜精子组相比，冷冻精子组的第一次 ET 的 LBR 降低了 4.57%，每次 ET 的 LBR 降低了 3.95%。与使用新鲜精子相比，每次 ET 的生化流产率也略有增加 2.66%。多变量分析后，所有这些差异仍然具有统计学显着性（调整后的 P ≤ 0.001）。每个替换胚胎和每个 ET 的 CLBR 存在统计学显着差异，但每个使用卵母细胞的 CLBR 没有显着差异（调整后的 P = 0.071）。尽管各组之间存在统计学差异，但使用冷冻精子的患者平均只需要多注射 0.54 个卵母细胞、多移植 0.45 个胚胎以及多进行 0.41 次 ET 手术。与新鲜样本相比，实现活产。局限性、谨慎原因 该研究的回顾性使得数据在源临床和周期记录注释期间存在偏差或潜在错误。本研究使用多变量分析来尽可能控制偏差。使用卵母细胞捐赠模型还有助于减少卵母细胞质量因素的异质性。研究结果的更广泛意义 这项研究中包含的大样本量可以检测各组之间周期成功率的微小变化。尽管具有统计学意义，但使用冷冻精子时 PR、LBR 和 CLBR 的降低在临床上可能会被忽视，而精子冷冻保存有许多好处。研究资助/竞争利益 未声明。试用注册号 不适用