Abstract
Background:
The study aim was to validate Beckman Coulter’s fully automated Access Immunoassay System (BC Access assay) for anti-Müllerian hormone (AMH) and compare it with Beckman Coulter’s Modified Manual Generation II assay (BC Mod Gen II), with regard to cycle AMH fluctuations and antral follicle counts.
Methods:
During one complete menstrual cycle, transvaginal ultrasound was performed on regularly menstruating women (n=39; 18–40years) every 2 days until the dominant ovarian follicle reached 16mm, then daily until observed ovulation; blood samples were collected throughout the cycle. Number and size of antral follicles was determined and AMH levels measured using both assays.
Results:
AMH levels measured by the BC Access assay vary over ovulatory menstrual cycles, with a statistically significant pre-ovulatory decrease from –5 to +2 days around objective ovulation. Mean luteal AMH levels were significantly lower (–7.99%) than mean follicular levels but increased again towards the end of the luteal phase. Antral follicle count can be estimated from AMH (ng/mL, BC Access assay) concentrations on any follicular phase day. BC Access assay-obtained AMH values are considerably lower compared with the BC Mod Gen II assay (–19% on average); conversion equation: AMH BC Access (ng/mL)=0.85 [AMH BC Mod Gen II (ng/mL)]0.95.
Conclusions:
AMH levels vary throughout the cycle, independently of assay utilised. A formula can be used to convert BC Access assay-obtained AMH levels to BC Mod Gen II values. The number of antral follicles can be consistently estimated from pre-ovulatory AMH levels using either assay.
Acknowledgments
The authors wish to thank all team members of green-ivf, especially Mrs Silvia Heil and Ms Jennifer Neye, for helping to recruit volunteers, volunteer support during the study, data recording, and documentation work. Editorial support was provided by integrated medhealth communication (imc), supported by SPD Development Company Ltd.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission. JS and EG provided statistical analysis and critical discussion and JS was involved in writing of the manuscript. JR was involved in study design, sonography, and critical discussion. DB and JH conducted all AMH measurements. DF was involved in writing of the manuscript. GF was involved in study design and critical discussion. SJ participated in study design and management, analysis, manuscript drafting, and critical discussion. CG participated in study design, sonography, analysis, manuscript writing and drafting, and critical discussion.
Research funding: This study was funded by SPD Development Company Ltd.
Employment or leadership: Christian Gnoth: principle investigator of clinical studies on the performance of fertility monitors, partly supported by SPD (Swiss Precision Diagnostics) Development Company Ltd. Receipt of speaker’s fees by Beckman Coulter, Sinsheim, Germany. Sarah Johnson, Dave Broomhead: employees of SPD Development company Ltd., a fully owned subsidiary of SPD (Swiss Precision Diagnostics) Development Company Ltd., the manufacturers of Clearblue pregnancy and fertility tests. Julia Schiffner, Judith Roos, Joseph van Helden, Erhard Godehardt, Daniel Fehr, Günter Freundl: nothing to declare.
Clinical trial registration number: NCT01802060
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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