Background

Systematic monitoring of key performance indicators (KPI) is an important component of quality management within the IVF laboratory and, as success of assisted reproduction depends on many variables, it is important to examine how each variable can be optimized to achieve the best possible outcome for patients.

Objective

To analyze how the design of a QMS impacts homogenization, safety, and efficacy in multiple fertility centers.

Study Design Multicenter, retrospective cohort study with 188,251 patients who underwent 246,988 assisted reproductive treatments at 14 private centers belonging to IVI-RMA clinics between January 2005 and December 2019. Data were stratified by year, clinic, and patient group (standard patient cycles with no PGT-A, standard patients with PGT-A, and oocyte donation patients). Unadjusted and adjusted logistic regression models with other known predictors were made to analyze the impact and the interactions of policies. Main outcomes were determined per clinic and summarized per year as the median of the rates of the clinics; each clinic had the same weight independent of the number of cycles.

Results

Up to 188,251 patients were treated, for a total of 246,988 IVF cycles and 356,433 procedures. The introduction of standard operating procedures, trophectoderm biopsies, and blastocyst-stage transfers, coupled with an increased proportion of PGT-A cycles, led to improved outcomes while maximizing the number of single embryo transfers, driving a significant decrease in the number of multiple pregnancies while improving live birth rates. In terms of the live-birth rate per transfer, the interventions with greater impact over time in logistic regression analysis were 24-chromosome analysis and the introduction of benchtop incubators (odds ratio 1.92 [95% confidence interval 1.81 to 2.05]; p < 0.001). The odd ratios of the policies remained significant and very similar in the unadjusted and adjusted models.

Conclusions

The greatest impact on live-birth rate per cycle was obtained with a cumulative effect of all policies, especially in egg donation patients. In patients without PGT-A changing embryo culture conditions and blastocyst stage transfer had the greatest impact; in patients with PGT-A, trophectoderm biopsy. Standardizing procedures was essential in reducing variability among clinics and implementing changes.

中文翻译：

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通过在临床实践中应用干预措施并衡量其影响来提高成功率：对超过 240,000 个周期的多中心回顾性分析

背景

关键绩效指标 (KPI) 的系统监控是 IVF 实验室内质量管理的重要组成部分，并且由于辅助生殖的成功取决于许多变量，因此检查如何优化每个变量以实现最佳可能结果非常重要。患者。

客观的

分析质量管理体系的设计如何影响多个生育中心的同质化、安全性和有效性。

研究设计多中心、回顾性队列研究，纳入 188,251 名患者，这些患者于 2005 年 1 月至 2019 年 12 月期间在属于 IVI-RMA 诊所的 14 个私人中心接受了 246,988 次辅助生殖治疗。数据按年份、诊所和患者组进行分层（标准患者周期，无PGT-A、PGT-A 标准患者和卵母细胞捐赠患者）。使用其他已知预测变量建立未调整和调整的逻辑回归模型来分析政策的影响和相互作用。主要结果是根据每个诊所确定的，并每年总结为诊所比率的中位数；每个诊所都有相同的权重，与周期数无关。

结果

多达 188,251 名患者接受了治疗，总共 246,988 个 IVF 周期和 356,433 例手术。标准操作程序、滋养外胚层活检和囊胚期移植的引入，加上 PGT-A 周期比例的增加，改善了结果，同时最大限度地提高了单胚胎移植的数量，从而显着减少了多胎妊娠的数量同时提高活产率。就每次转移的活产率而言，在逻辑回归分析中随着时间的推移影响较大的干预措施是 24 染色体分析和引入台式培养箱（比值比 1.92 [95% 置信区间 1.81 至 2.05]；p < 0.001 ）。在未调整和调整模型中，政策的奇数比仍然显着且非常相似。

结论

所有政策的累积效应对每个周期的活产率影响最大，特别是对于卵子捐赠患者。在没有 PGT-A 的患者中，改变胚胎培养条件和囊胚阶段移植的影响最大；PGT-A 患者的滋养外胚层活检。标准化程序对于减少诊所之间的差异和实施变革至关重要。