Department of Gynaecology, Division of Gynaecology and Reproductive Medicine, Fertility Center, Humanitas Research Hospital, IRCCS, 20089 Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy.
Department of Gynaecology, Division of Gynaecology and Reproductive Medicine, Fertility Center, Humanitas Research Hospital, IRCCS, 20089 Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy.
Eur J Obstet Gynecol Reprod Biol. 2024 Oct;301:24-30. doi: 10.1016/j.ejogrb.2024.07.049. Epub 2024 Jul 25.
The objectives of the study were to correlate live birth rate with the initial level of β-hCG in all patients undergoing embryo transfer and develop a predictive model of live birth based on patients' and assisted reproductive technology (ART) characteristics.
Single-center retrospective cohort study, including a total of 7587 positive first serum β-hCG from women who performed fresh and frozen embryo transfer. Twenty-one variables related to patient characteristics and treatment modalities were analyzed by step-wise univariate analysis followed by multivariate analysis. The study included women between 18 and 45 years with a positive (>20 IU/L) serum β-hCG between January 2011 and December 2020 while it excluded cycles from donation of gametes, PGT and >3 embryos transferred simultaneously.
Among the positive serum β-hCG measurements 5085 (67.0 %) resulted in live births. β-hCG was higher in the live birth group (691 IU/L) compared to the failed pregnancies group (304 IU/L) (p500 IU/mL provided a positive predictive value for live birth of 85.3 % (95 %CI 84.0-86.4). Failed pregnancies were more common among older maternal and paternal age. Previous abortions were more common in the failed pregnancies group (25.0 %) compared to the live birth group (19.4 %). The most common indication to treatment was male infertility, accounting for a larger portion in the live birth group (41.7 %). At multivariate analysis, the factors independently associated with live birth were: first serum β-hCG (OR 1.35, 95 %CI 1.32-1.37), maternal age (OR 0.93, 95 %CI 0.91-0.95), previous abortions (OR 0.77, 95 % CI 0.68-0.88). The number of embryos transferred showed a positive correlation below a maternal age of 39 (<35 years old OR 1.60, CI 95 % 1.32-1.94; <39 years old OR 1.27 CI 95 % 1.09-1.47). The prediction model incorporating these four variables resulted in a sensitivity and specificity with an area under the ROC curve of 0.798.
The study confirms the importance of the first value of β-hCG and proposes a predictive model that takes into account maternal age, number of embryos transferred, and obstetric history, thereby aiding in couples' counseling and ultimately improve patients' care.
本研究旨在探讨所有接受胚胎移植患者的活产率与初始β-hCG 水平的相关性，并基于患者和辅助生殖技术（ART）特征建立活产预测模型。
单中心回顾性队列研究，共纳入 7587 例在我院行新鲜及冷冻胚胎移植的血清β-hCG 阳性患者。采用逐步单因素分析和多因素分析对与患者特征和治疗方式相关的 21 个变量进行分析。本研究纳入了年龄在 18 至 45 岁之间、血清β-hCG 水平大于 20IU/L 的患者。纳入标准为 2011 年 1 月至 2020 年 12 月之间接受治疗的患者，排除了供卵、PGT 和同时移植 3 个以上胚胎的周期。
在所有血清β-hCG 阳性的患者中，有 5085 例（67.0%）成功妊娠。与未妊娠组（304IU/L）相比，活产组的β-hCG 水平更高（691IU/L）（p<0.001）。β-hCG>500IU/mL 对活产的阳性预测值为 85.3%（95%CI 84.0-86.4）。高龄产妇和高龄父亲更容易发生未妊娠。与活产组（19.4%）相比，未妊娠组中（25.0%）既往流产史更为常见。最常见的治疗指征是男性不育，在活产组中占比更大（41.7%）。多因素分析结果显示，与活产相关的独立因素包括：首诊β-hCG（OR 1.35，95%CI 1.32-1.37）、母亲年龄（OR 0.93，95%CI 0.91-0.95）、既往流产史（OR 0.77，95% CI 0.68-0.88）。胚胎移植数量与母亲年龄存在正相关，<39 岁时（<35 岁 OR 1.60，CI 95% 1.32-1.94；<39 岁 OR 1.27，CI 95% 1.09-1.47）。纳入这四个变量的预测模型具有较高的灵敏度和特异性，ROC 曲线下面积为 0.798。
本研究证实了首诊β-hCG 水平的重要性，并提出了一种预测模型，该模型考虑了母亲年龄、胚胎移植数量和产科病史，从而有助于夫妇咨询，并最终改善患者的治疗效果。
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