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

  • Clarisa R. Gracia
  • Sanghyuk S. Shin
  • Maureen Prewitt
  • Janna S. Chamberlin
  • Lori R. Lofaro
  • Kristin L. Jones
  • Marta Clendenin
  • Katherine E. Manzanera
  • Dennis L. Broyles
Reproductive Physiology and Disease

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

Ovarian reserve AMH Menstrual cycle Intra-cycle variability Anti-Mullerian hormone Endocrinology Access AMH 

Notes

Acknowledgements

Kerrie Rossow and Thong Her, Beckman Coulter, Chaska, for their help with specimen testing, and Kim Doeden and Yang Bai, Beckman Coulter, Carlsbad, for their assistance with study management and data analyses, respectively.

Compliance with ethical standards

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

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Clarisa R. Gracia
    • 1
    • 2
  • Sanghyuk S. Shin
    • 3
  • Maureen Prewitt
    • 1
  • Janna S. Chamberlin
    • 3
  • Lori R. Lofaro
    • 3
  • Kristin L. Jones
    • 4
  • Marta Clendenin
    • 3
  • Katherine E. Manzanera
    • 3
  • Dennis L. Broyles
    • 3
  1. 1.Department of Obstetrics and GynecologyUniversity of PennsylvaniaPhiladelphiaUSA
  2. 2.Division of Reproductive EndocrinologyUniversity of PennsylvaniaPhiladelphiaUSA
  3. 3.Beckman Coulter, Inc.CarlsbadUSA
  4. 4.Beckman Coulter, Inc.ChaskaUSA

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