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Multicenter Study
. 2018 May;35(5):777-783.
doi: 10.1007/s10815-018-1141-5. Epub 2018 Mar 14.

Multi-center clinical evaluation of the Access AMH assay to determine AMH levels in reproductive age women during normal menstrual cycles

Clarisa R Gracia  1   2 , Sanghyuk S Shin  3 , Maureen Prewitt  4 , Janna S Chamberlin  3 , Lori R Lofaro  3 , Kristin L Jones  5 , Marta Clendenin  3 , Katherine E Manzanera  3 , Dennis L Broyles  3
Affiliations
Multicenter Study

Multi-center clinical evaluation of the Access AMH assay to determine AMH levels in reproductive age women during normal menstrual cycles

Clarisa R Gracia et al. J Assist Reprod Genet. 2018 May.

Abstract

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.

Keywords: AMH; Access AMH; Anti-Mullerian hormone; Endocrinology; Intra-cycle variability; Menstrual cycle; Ovarian reserve.

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Conflict of interest statement

IRB approval was obtained at each site, and informed consent was obtained from all participants prior to enrollment.

Figures

Fig. 1
Fig. 1
Distribution of mean AMH values per subject
Fig.2
Fig.2
Median AMH values across menstrual cycle. Boxplot of AMH values across different days of menstrual cycle utilizing data from 384 samples from 50 subjects is showing that median AMH values did not vary significantly across the menstrual cycle
Fig. 3
Fig. 3
Individual AMH values across the menstrual cycle for all subjects
Fig. 4
Fig. 4
Mean AMH values by age per subject. Scatter plot of mean AMH values vs age per subject utilizing 50 eligible subjects is showing that mean AMH values were negatively correlated with age. A fitted line with slope = − 0.2466 generated by simple linear regression is showing the same trend
Fig. 5
Fig. 5
AMH values across menstrual cycle per subject. Repeated AMH results across the menstrual cycle of all eligible subjects enrolled in this study are shown, with results displayed in order of increasing median AMH values. Each bar represents the range of AMH results for a given subject, with the purple star representing the median of AMH results and the color type representing the corresponding age group
See this image and copyright information in PMC

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