多中心临床评估 Access AMH 检测法在正常月经周期的生育期妇女中测定 AMH 水平。
Multi-center clinical evaluation of the Access AMH assay to determine AMH levels in reproductive age women during normal menstrual cycles.
机构信息
Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA.
Division of Reproductive Endocrinology, University of Pennsylvania, 3701 Market St, Suite 800, Philadelphia, PA, 19104, USA.
出版信息
J Assist Reprod Genet. 2018 May;35(5):777-783. doi: 10.1007/s10815-018-1141-5. Epub 2018 Mar 14.
BACKGROUND
AMH is widely used for assessing ovarian reserve, and it is particularly convenient, because it is thought to have minimal variability throughout the menstrual cycle. However, studies assessing the stability of AMH over the menstrual cycle have been conflicting.
PURPOSE
The purpose of this study is to determine whether AMH levels vary across the normal menstrual cycle.
DESIGN
A multi-center, prospective cohort study conducted at three US centers.
METHODS
Fifty females with regular menstrual cycles aged 18-45 underwent serial venipuncture every 3-5 days starting in the early follicular phase and lasting up to 10 collections. AMH was tested using the Access 2 immunoassay system.
RESULTS
Age-adjusted mixed-effect models utilizing data from 384 samples from 50 subjects demonstrated a within subject standard deviation of 0.81 (95% CI 0.75-0.88) with a coefficient of variation of 23.8% across the menstrual cycle and between subject standard deviation of 2.56 (95% CI 2.13-3.21) with a coefficient of variation of 75.1%. Intra-class correlation (ICC) of AMH across the menstrual cycle was 0.91.
CONCLUSION
Overall, AMH levels, using the automated Access AMH assay, appear to be relatively stable across the menstrual cycle. Fluctuations, if any, appear to be small, and therefore, clinicians may advise patients to have AMH levels drawn at any time in the cycle.
背景
AMH 广泛用于评估卵巢储备功能，因其被认为在整个月经周期中变化极小，所以特别方便。然而，评估 AMH 在月经周期中稳定性的研究结果存在矛盾。
目的
本研究旨在确定 AMH 水平是否在正常月经周期中发生变化。
设计
在美国 3 个中心进行的多中心前瞻性队列研究。
方法
50 名年龄在 18-45 岁、月经周期规律的女性，在早期卵泡期开始每隔 3-5 天进行一次静脉穿刺，共进行 10 次采集。使用 Access 2 免疫测定系统检测 AMH。
结果
利用 50 名受试者的 384 个样本数据，经过年龄调整的混合效应模型显示，在月经周期内，个体内标准差为 0.81（95%置信区间为 0.75-0.88），变异系数为 23.8%；个体间标准差为 2.56（95%置信区间为 2.13-3.21），变异系数为 75.1%。AMH 在月经周期内的组内相关系数（ICC）为 0.91。
结论
总体而言，使用自动化 Access AMH 检测，AMH 水平在月经周期中似乎相对稳定。如果存在波动，幅度也很小，因此，临床医生可能会建议患者在周期的任何时间进行 AMH 水平检测。
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