Antimüllerian hormone to determine polycystic ovarian morphology

Alexandra Dietz de Loos*, Martin Hund, Katharina Buck, Cindy Meun, Johanna Sillman, Joop S.E. Laven

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Objective: To determine a cutoff for the Elecsys AMH Plus immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) to identify polycystic ovarian morphology (PCOM), a polycystic ovary syndrome (PCOS) criterion. Design: The AMH Protein in Humans for polycystic ovaRian mOrphology DIagnostic TEsting (APHRODITE) study was a retrospective, multicenter, case-control study. The serum antimüllerian hormone (AMH) level was measured using the Elecsys AMH Plus immunoassay. The antral follicle count was determined using transvaginal ultrasound. An AMH cutoff was derived and validated in separate cohorts with cases of PCOS with full phenotype A (oligo/anovulation, hyperandrogenism, and PCOM) versus that with controls. Exploratory analyses of age and PCOS phenotype were performed. Setting: Not applicable. Patient(s): Polycystic ovary syndrome-positive (PCOS A–D per the Rotterdam criteria) and PCOS-negative women aged 25–45 years. Intervention(s): None. Main Outcome Measure(s): A validated cutoff for AMH using the Elecsys AMH Plus assay for PCOM. Result(s): In the validation cohort (455 cases and 500 controls), an AMH cutoff of 3.2 ng/mL (23 pmol/L) resulted in a sensitivity of 88.6% (95% confidence interval [CI] 85.3–91.3) and specificity of 84.6% (95% CI 81.1–87.7) for PCOM diagnosis as well as an area under the receiver-operator characteristic curve of 93.6% (95% CI 92.2–95.1). In women aged 25–35 years, the sensitivity and specificity for the cutoff were 88.5% and 80.3%, respectively, versus 77.8% and 90.1%, respectively, in women aged 36–45 years. The results were consistent across PCOS phenotypes A–D. Conclusion(s): The Elecsys AMH Plus immunoassay, with a cutoff of 3.2 ng/mL (23 pmol/L), is a robust method for identifying PCOM to aid in PCOS diagnosis.

Original languageEnglish
Pages (from-to)1149-1157
Number of pages9
JournalFertility and Sterility
Volume116
Issue number4
DOIs
Publication statusPublished - 1 Oct 2021

Bibliographical note

Funding Information:
Supported by Roche Diagnostics International Ltd (Rotkreuz, Switzerland).

Funding Information:
Supported by Roche Diagnostics International Ltd (Rotkreuz, Switzerland). A.D.L. has nothing to disclose. M.H. is an employee of Roche Diagnostics International Ltd, holds stock in F. Hoffmann-La Roche, and reports being an inventor of a pending patent related to a method of assessing a female's risk of having polycystic ovary syndrome as well as products and uses relating thereto. K.B. is an employee of Roche Diagnostics GmbH and also reports being an inventor of a pending patent related to a method of assessing a female's risk of having PCOS as well as products and uses relating thereto. C.M. has nothing to disclose. J.S. is an employee of Roche Diagnostics International Ltd. J.S.E.L. reports receipt of research grants and personal fees from Ferring and Ansh Labs; research grants from Astellas, Dutch Heart Association, and ZonMw; and personal fees from Titus Health Care.

Funding Information:
A.D.L. has nothing to disclose. M.H. is an employee of Roche Diagnostics International Ltd, holds stock in F. Hoffmann-La Roche, and reports being an inventor of a pending patent related to a method of assessing a female’s risk of having polycystic ovary syndrome as well as products and uses relating thereto. K.B. is an employee of Roche Diagnostics GmbH and also reports being an inventor of a pending patent related to a method of assessing a female’s risk of having PCOS as well as products and uses relating thereto. C.M. has nothing to disclose. J.S. is an employee of Roche Diagnostics International Ltd. J.S.E.L. reports receipt of research grants and personal fees from Ferring and Ansh Labs; research grants from Astellas, Dutch Heart Association, and ZonMw; and personal fees from Titus Health Care.

Publisher Copyright:
© 2021 The Authors

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