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评价 Elecsys 抗苗勒管激素检测在 GnRH 拮抗剂方案控制性卵巢刺激中超反应预测中的价值。

Evaluation of the Elecsys anti-Müllerian hormone assay for the prediction of hyper-response to controlled ovarian stimulation with a gonadotrophin-releasing hormone antagonist protocol.

机构信息

Laboratory of Hormonology and Tumour Markers, Universitair Ziekenhuis Brussel, Free University of Brussels, Brussels, Belgium.

Roche Diagnostics GmbH, Penzberg, Germany.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2019 May;236:133-138. doi: 10.1016/j.ejogrb.2019.02.022. Epub 2019 Mar 2.

Abstract

OBJECTIVE

This non-interventional study aimed to validate a pre-specified anti-Müllerian hormone (AMH) cut-off of 15 pmol/L (2.10 ng/mL) for the prediction of hyper-response to controlled ovarian stimulation (COS) using the fully automated Elecsys AMH immunoassay.

STUDY DESIGN

One hundred and forty-nine women aged <44 years with regular menstrual cycles underwent COS with 150 IU/day follicle-stimulating hormone in a gonadotrophin-releasing hormone (GnRH) antagonist protocol. Response to COS (poor vs normal vs hyper-response) was defined by number of oocytes retrieved and occurrence of ovarian hyper-stimulation syndrome (OHSS).

RESULTS

Significant differences were seen between response classes for the number of follicles prior to follicle puncture (p < 0.001), the number of retrieved oocytes (p < 0.001) and the occurrence of OHSS (p < 0.001), which were all highest in hyper-responders. The area under the receiver operating characteristic curve for AMH to predict hyper-response was 82.1% (95% confidence interval [CI]: 72.5-91.7). When applying the AMH cut-off of 15.0 pmol/L, a sensitivity of 81.3% (95%CI: 54.4-96.0) to predict hyper-response and a specificity of 64.7% (95%CI: 55.9-72.8) to identify poor/normal responders was reached.

CONCLUSION

The Elecsys AMH assay can reliably predict hyper-response to COS in women undergoing a GnRH antagonist treatment protocol.

摘要

目的

本非介入性研究旨在验证使用全自动 Elecsys AMH 免疫分析法,将抗苗勒管激素(AMH)的预设截断值 15pmol/L(2.10ng/mL)用于预测控制性卵巢刺激(COS)的高反应。

设计

149 名年龄<44 岁、月经周期规律的女性接受了促性腺激素释放激素(GnRH)拮抗剂方案下的 150IU/天卵泡刺激素的 COS。根据获得的卵母细胞数量和卵巢过度刺激综合征(OHSS)的发生情况,将 COS 反应(差、正常和高反应)定义。

结果

在卵泡穿刺前卵泡数量(p<0.001)、获得的卵母细胞数量(p<0.001)和 OHSS 的发生(p<0.001)方面,反应类别之间存在显著差异,这些差异在高反应者中最高。AMH 预测高反应的受试者工作特征曲线下面积为 82.1%(95%置信区间:72.5-91.7)。当应用 AMH 截断值 15.0pmol/L 时,预测高反应的敏感性为 81.3%(95%CI:54.4-96.0),特异性为 64.7%(95%CI:55.9-72.8),以识别差/正常反应者。

结论

Elecsys AMH 测定法可可靠地预测 GnRH 拮抗剂治疗方案中女性对 COS 的高反应。

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