DataSheet_1_Development and validation of a nomogram for predicting ongoing pregnancy in single vitrified-warmed blastocyst embryo transfer cycles.docx

IntroductionThe global adoption of the “freeze-all strategy” has led to a continuous increase in utilization of single vitrified-warmed blastocyst embryo transfer (SVBT) owing to its clinical effectiveness. Accurate prediction of clinical pregnancy is crucial from a patient-centered perspective. However, this remains challenging, with inherent limitations due to the absence of precise and user-friendly prediction tools. Thus, this study primarily aimed to develop and assess a nomogram based on quantitative clinical data to optimize the efficacy of personalized prognosis assessment.
Materials and methodsWe conducted a retrospective cohort analysis of ongoing pregnancy data from 658 patients with infertility who underwent SVBT at our center between October 17, 2017, and December 18, 2021. Patients were randomly assigned to the training (n=461) or validation (n=197) cohort for nomogram development and testing, respectively. A nomogram was constructed using the results of the multivariable logistic regression (MLR), which included clinical covariates that were assessed for their association with ongoing pregnancy.
ResultsThe MLR identified eight significant variables that independently predicted ongoing pregnancy outcomes in the study population. These predictors encompassed maternal physiology, including maternal age at oocyte retrieval and serum anti-Müllerian hormone levels; uterine factors, such as adenomyosis; and various embryo assessment parameters, including the number of fertilized embryos, blastocyst morphology, blastulation day, blastocyst re-expansion speed, and presence of embryo string. The area under the receiver operating characteristic curve in our prediction model was 0.675 (95% confidence interval [CI], 0.622–0.729) and 0.656 (95% CI, 0.573–0.739) in the training and validation cohorts, respectively, indicating good discrimination performance in both cohorts.
ConclusionsOur individualized nomogram is a practical and user-friendly tool that can provide accurate and useful SVBT information for patients and clinicians. By offering this model to patients, clinical stakeholders can alleviate uncertainty and confusion about fertility treatment options and enhance patients’ confidence in making informed decisions.

前言
全球范围内“全胚胎冷冻策略”的普及，因其临床疗效确切，使得单玻璃化复苏囊胚胚胎移植（single vitrified-warmed blastocyst embryo transfer, SVBT）的应用持续增长。从以患者为中心的视角来看，准确预测临床妊娠结局至关重要。然而，目前仍存在挑战：由于缺乏精准且易用的预测工具，该领域存在固有局限性。因此，本研究旨在基于定量临床数据构建并验证列线图（nomogram），以优化个性化预后评估的效能。

材料与方法
本研究对2017年10月17日至2021年12月18日期间，于本中心接受单玻璃化复苏囊胚胚胎移植（SVBT）的658例不孕症患者的持续妊娠数据进行回顾性队列分析。将患者随机分为训练队列（n=461）与验证队列（n=197），分别用于列线图的构建与验证。本研究采用多变量logistic回归（multivariable logistic regression, MLR）分析结果构建列线图，纳入了与持续妊娠结局相关的临床协变量并进行评估。

结果
多变量logistic回归分析共筛选出8个对研究人群的持续妊娠结局具有独立预测价值的显著变量。这些预测因子涵盖了母体生理指标（包括取卵时母亲年龄、血清抗缪勒管激素（anti-Müllerian hormone）水平）、子宫因素（如子宫腺肌症）以及多项胚胎评估参数（包括受精胚胎数、囊胚形态、囊胚形成日、囊胚复扩张速度及胚胎串存在情况）。本预测模型的受试者工作特征曲线（receiver operating characteristic curve）下面积在训练队列中为0.675（95%置信区间[CI]：0.622~0.729），在验证队列中为0.656（95%CI：0.573~0.739），表明两个队列均具有良好的区分效能。

结论
本研究所构建的个性化列线图是一款实用且易用的工具，可为患者与临床医师提供准确且有价值的单玻璃化复苏囊胚胚胎移植（SVBT）相关信息。通过向患者提供该模型，临床相关方能够减轻患者对生育治疗选择的不确定性与困惑，并增强患者做出知情决策的信心。