Abstract：
OBJECTIVE: 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?
CONCLUSIONS: 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.
BACKGROUND: 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.
METHODS: 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.
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.
RESULTS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
BACKGROUND: None declared.
BACKGROUND: Not applicable.
CONCLUSIONS: 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.
BACKGROUND: 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.
METHODS: 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.
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.
RESULTS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
BACKGROUND: None declared.
BACKGROUND: Not applicable.
摘要：
目的：与卵母细胞捐献ICSI周期中的新鲜精子样本相比，冷冻精子的使用是否会影响活产率（LBR）和累积LBR（CLBR）？
结论：尽管妊娠率（PRs）和LBR略有下降，以及每个胚胎替换和每个胚胎移植（ET）的CLBR，当使用冷冻精子样本与新鲜射精相比时，其临床影响有限.
背景：精子冷冻保存是全球生殖诊所日常工作的一部分，因为它在周期计划中具有许多优势。尽管如此，就其对ICSI周期结果的影响而言，缺乏共识。先前的研究显示出相互矛盾的结论，并且集中在不同的人群上，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：怀孕，每个ET的活产率和流产率。这项研究报告了这些测量加上CLBR，这更准确地反映了该技术对获得新生儿的可能性的影响。
方法：回顾性多中心观察队列研究，包括从2008年1月至2022年6月的37.041对夫妇和44.423ICSI程序的数据。使用冷冻精子的组包括23.852个移植胚胎和108.661个授精卵母细胞，而新鲜样品组包括73.953个胚胎被替换和381.509个卵母细胞被注射。
方法：使用Fisher精确检验和卡方检验，在组间比较首次ET和每次ET测量的结果。视情况而定。根据临床相关的共变量，使用二元物流回归模型来调整分析。Kaplan-Meier曲线绘制了每个授精卵母细胞的CLBR，每个被替换的胚胎和每个ET，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。
结果：冷冻精子组生化指标略低（3.55%和2.56%），与使用新鲜精子的周期相比，临床（3.68％和3.54％）和持续（3.63％和3.15％）PR，分别,均为第一次ET和每次ET。冷冻精子组的LBR比新鲜精子组低4.57％，低3.95％。使用冷冻精子与新鲜精子时，每个ET的生化流产率也有2.66％的细微增加。在多变量分析后，所有这些差异仍具有统计学意义（调整后的P≤0.001）。每个替换胚胎和每个ET的CLBR差异有统计学意义，但每个使用的卵母细胞差异无统计学意义（调整后的P=0.071）。尽管组间差异具有统计学意义，那些使用冷冻精子的人只需要注射0.54个卵母细胞，移植的胚胎增加了0.45个，ET程序增加了0.41个，平均而言,与新鲜样本相比，实现活产。
结论：本研究的回顾性性质使数据在对来源的临床和周期记录进行注释时出现偏差或潜在错误。本研究使用多变量分析来尽可能地控制偏差。使用卵母细胞捐献模型还有助于减少卵母细胞质量因子的异质性。
结论：本研究中包含的大样本量允许检测组间周期成功率的微小变化。尽管具有统计学意义，减贫战略的减少，LBR,而CLBR在使用冷冻精子时可在临床上被忽视，有利于精子冷冻保存的许多好处。
背景：无声明。
背景：不适用。
结论：尽管妊娠率（PRs）和LBR略有下降，以及每个胚胎替换和每个胚胎移植（ET）的CLBR，当使用冷冻精子样本与新鲜射精相比时，其临床影响有限.
背景：精子冷冻保存是全球生殖诊所日常工作的一部分，因为它在周期计划中具有许多优势。尽管如此，就其对ICSI周期结果的影响而言，缺乏共识。先前的研究显示出相互矛盾的结论，并且集中在不同的人群上，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：怀孕，每个ET的活产率和流产率。这项研究报告了这些测量加上CLBR，这更准确地反映了该技术对获得新生儿的可能性的影响。
方法：回顾性多中心观察队列研究，包括从2008年1月至2022年6月的37.041对夫妇和44.423ICSI程序的数据。使用冷冻精子的组包括23.852个移植胚胎和108.661个授精卵母细胞，而新鲜样品组包括73.953个胚胎被替换和381.509个卵母细胞被注射。
方法：使用Fisher精确检验和卡方检验，在组间比较首次ET和每次ET测量的结果。视情况而定。根据临床相关的共变量，使用二元物流回归模型来调整分析。Kaplan-Meier曲线绘制了每个授精卵母细胞的CLBR，每个被替换的胚胎和每个ET，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。
结果：冷冻精子组生化指标略低（3.55%和2.56%），与使用新鲜精子的周期相比，临床（3.68％和3.54％）和持续（3.63％和3.15％）PR，分别,均为第一次ET和每次ET。冷冻精子组的LBR比新鲜精子组低4.57％，低3.95％。使用冷冻精子与新鲜精子时，每个ET的生化流产率也有2.66％的细微增加。在多变量分析后，所有这些差异仍具有统计学意义（调整后的P≤0.001）。每个替换胚胎和每个ET的CLBR差异有统计学意义，但每个使用的卵母细胞差异无统计学意义（调整后的P=0.071）。尽管组间差异具有统计学意义，那些使用冷冻精子的人只需要注射0.54个卵母细胞，移植的胚胎增加了0.45个，ET程序增加了0.41个，平均而言,与新鲜样本相比，实现活产。
结论：本研究的回顾性性质使数据在对来源的临床和周期记录进行注释时出现偏差或潜在错误。本研究使用多变量分析来尽可能地控制偏差。使用卵母细胞捐献模型还有助于减少卵母细胞质量因子的异质性。
结论：本研究中包含的大样本量允许检测组间周期成功率的微小变化。尽管具有统计学意义，减贫战略的减少，LBR,而CLBR在使用冷冻精子时可在临床上被忽视，有利于精子冷冻保存的许多好处。
背景：无声明。
背景：不适用。
