Innocenti Federica, Cermisoni Greta Chiara, Taggi Marilena, Casciani Valentina, Soscia Daria Maria, Dovere Lisa, Stoppa Marta, Albricci Laura, Vaiarelli Alberto, Coticchio Giovanni, Maggiulli Roberta, Rienzi Laura, Cimadomo Danilo
IVIRMA Global Research Alliance, Genera, Clinica Valle Giulia, Rome, Italy.
Department of Biomedicine and Prevention, Tor Vergata University, Rome, Italy.
Hum Reprod. 2025 Sep 5. doi: 10.1093/humrep/deaf164.
Do IVF laboratory workflows influence the mean blastulation rate per cohort of inseminated metaphase II oocytes (m-BR)?
Neither the total number of procedures nor the workload per operator affected m-BR; instead, each additional hour in the interval from ovulation trigger to oocyte denudation (range 36-44 h) was associated with a measurable decline, especially beyond the 40-h threshold.
Control of laboratory conditions and standardized protocols are essential for optimizing m-BR in IVF. While advancements in technology and culture systems have improved ART outcomes, the effect of laboratory managerial decisions and procedural timing on embryological outcomes remains unclear. Previous studies have suggested that factors, such as prolonged oocyte handling, suboptimal culture conditions, and organizational inefficiencies, may affect in vitro embryo development, but available data are still limited.
STUDY DESIGN, SIZE, DURATION: This retrospective study analyzed 7986 ICSI cycles performed between 2015 and 2022 at a private IVF center. Data were automatically registered and then retrospectively extracted from an Electronic Witnessing System to evaluate workload distribution and procedural timings. The study aimed to assess whether variations in laboratory managerial decisions influence the m-BR.
PARTICIPANTS/MATERIALS, SETTING, METHODS: The study included all patients undergoing ICSI with fresh own oocytes. Metrics under investigation included the number of daily procedures overall and per operator and procedural timings, such as the interval between ovulation trigger and oocyte denudation. Results were adjusted for confounders, including maternal age, male factor infertility, and culture conditions. Multivariate linear regression and generalized estimating equations were used to assess associations with m-BR, accounting for repeated measures in couples undergoing multiple retrievals.
The overall m-BR was 35.7 ± 28.1% with 79% of the cycles resulting in at least one blastocyst obtained. No significant association was found between daily workload and m-BR, indicating that the number of daily procedures did not impact laboratory performance. After adjusting for confounders (maternal age, sperm factor, incubation conditions, and culture medium type), only the timing between ovulation trigger and oocyte denudation emerged as critical. A consistent and significant decline in m-BR was observed with each additional hour of delay between 36- and 44-h post-trigger (unstandardized coefficient B: -1.6%, 95% CI: -2.1 to -1.1%). The time between oocyte retrieval and denudation (range: 2-6 h) showed a significant association with a lower chance to obtain at least one blastocyst in each ICSI cycle (adjusted OR: 0.91, 95% CI: 0.86-0.96, P < 0.001).
LIMITATIONS, REASONS FOR CAUTION: This was a retrospective single-center study. While the findings are robust and relevant for high-volume IVF laboratories, they may not be directly generalizable to smaller clinics with different workflows or lower caseloads. Additionally, only ICSI cycles were included; further studies are needed to confirm the findings for conventional IVF in different settings and patient populations.
These findings suggest that even large workloads can be managed without compromising IVF performance, provided that lab schedules and personnel are carefully coordinated to meet ideal timing requirements. In the future, artificial intelligence models may support these lab management activities by predicting workloads and helping maintain timely schedules.
STUDY FUNDING/COMPETING INTEREST(S): No funding. The authors declare no conflict of interest related with the content of this study.
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体外受精(IVF)实验室工作流程是否会影响每个受精的中期II期卵母细胞队列的平均囊胚形成率(m-BR)?
操作总数和每位操作人员的工作量均未影响m-BR;相反,从排卵触发到卵母细胞剥脱的间隔时间每增加一小时(范围为36 - 44小时),m-BR就会出现可测量的下降,尤其是超过40小时的阈值后。
控制实验室条件和标准化方案对于优化IVF中的m-BR至关重要。虽然技术和培养系统的进步改善了辅助生殖技术(ART)的结果,但实验室管理决策和程序时间安排对胚胎学结果的影响仍不明确。先前的研究表明,诸如延长卵母细胞处理时间、次优培养条件和组织效率低下等因素可能会影响体外胚胎发育,但现有数据仍然有限。
研究设计、规模、持续时间:这项回顾性研究分析了2015年至2022年在一家私立IVF中心进行的7986个卵胞浆内单精子注射(ICSI)周期。数据自动记录,然后从电子见证系统中进行回顾性提取,以评估工作量分布和程序时间安排。该研究旨在评估实验室管理决策的变化是否会影响m-BR。
参与者/材料、设置、方法:该研究纳入了所有使用自身新鲜卵母细胞进行ICSI的患者。所研究的指标包括每日总体操作数量和每位操作人员的操作数量以及程序时间安排,例如排卵触发到卵母细胞剥脱的间隔时间。对结果进行了混杂因素调整,包括产妇年龄、男性因素不育和培养条件。使用多元线性回归和广义估计方程来评估与m-BR的关联,并考虑了多次取卵夫妇的重复测量情况。
总体m-BR为35.7±28.1%,79%的周期至少获得了一个囊胚。未发现每日工作量与m-BR之间存在显著关联,这表明每日操作数量不会影响实验室性能。在对混杂因素(产妇年龄、精子因素、培养条件和培养基类型)进行调整后,只有排卵触发到卵母细胞剥脱的时间被证明至关重要。在触发后36至44小时之间,每延迟一小时,m-BR就会出现持续且显著的下降(未标准化系数B:-1.6%,95%置信区间:-2.1至-1.1%)。卵母细胞采集到剥脱的时间(范围:2 - 6小时)与每个ICSI周期中至少获得一个囊胚的机会降低显著相关(调整后的比值比:0.91,95%置信区间:0.86 - 0.96,P < 0.001)。
局限性、谨慎原因:这是一项回顾性单中心研究。虽然研究结果对于大型IVF实验室具有稳健性和相关性,但它们可能无法直接推广到工作流程不同或病例量较低的小型诊所。此外,仅纳入了ICSI周期;需要进一步研究以在不同环境和患者群体中确认传统IVF的研究结果。
这些发现表明,只要实验室日程安排和人员得到精心协调以满足理想的时间要求,即使工作量很大也可以得到管理而不影响IVF性能。未来,人工智能模型可能通过预测工作量并帮助维持及时的日程安排来支持这些实验室管理活动。
研究资金/利益冲突:无资金支持。作者声明与本研究内容无利益冲突。
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