REPRODUCTIVE PHYSIOLOGY AND DISEASE
Multi-center clinical evaluation of the Access AMH assay
to determine AMH levels in reproductive age women during normal
Clarisa R. Gracia
Sanghyuk S. Shin
Janna S. Chamberlin
Lori R. Lofaro
Kristin L. Jones
Katherine E. Manzanera
Dennis L. Broyles
Received: 23 October 2017 /Accepted: 14 February 2018 /Published online: 14 March 2018
Springer Science+Business Media, LLC, part of Springer Nature 2018
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 3–5daysstartinginthe
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 is a product of granulosa cells of primordial follicles
that have undergone initial recruitment and is thought to re-
flect the size of the ovarian follicular reserve . Serum AMH
levels decline with age [2, 3] and were previously shown to
reach undetectable levels approximately 5 years before the
final menstrual period . More recent findings show that
AMH is measureable in perimenopausal women up to meno-
pause  and that AMH levels have been found to help predict
the final menstrual period in late reproductive age women [6,
7]. AMH has also been studied extensively in infertile women
pursuing assisted reproductive technologies. In this popula-
tion, AMH helps to predict response to ovarian stimulation
and is routinely used to tailor IVF stimulation regimens [8,
9]. Moreover, given the high correlation with antral follicle
counts, AMH has been identified as a potential surrogate
marker for polycystic ovary morphology in diagnosing poly-
cystic ovary syndrome (PCOS) [1, 10].
One of the advantages of AMH as compared to other mea-
sures of ovarian reserve, such as inhibin B or follicle-
stimulating hormone (FSH), is that it is thought to have
* Clarisa R. Gracia
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,
Beckman Coulter, Inc., Carlsbad, CA, USA
Beckman Coulter, Inc., Chaska, MN, USA
Journal of Assisted Reproduction and Genetics (2018) 35:777–783