Antimüllerian hormone to determine polycystic ovarian morphology

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. The AMH Protein in Humans for polycystic ovaRian mOrphology DIagnostic TEsting (APHR...

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Veröffentlicht in:Fertility and sterility 2021-10, Vol.116 (4), p.1149-1157
Hauptverfasser: Dietz de Loos, Alexandra, Hund, Martin, Buck, Katharina, Meun, Cindy, Sillman, Johanna, Laven, Joop S.E.
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container_issue 4
container_start_page 1149
container_title Fertility and sterility
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creator Dietz de Loos, Alexandra
Hund, Martin
Buck, Katharina
Meun, Cindy
Sillman, Johanna
Laven, Joop S.E.
description 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. 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. Not applicable. Polycystic ovary syndrome-positive (PCOS A–D per the Rotterdam criteria) and PCOS-negative women aged 25–45 years. None. A validated cutoff for AMH using the Elecsys AMH Plus assay for PCOM. 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. 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. Hormona antimülleriana para determinar la morfología del ovario poliquístico. Determinar un punto de corte para el inmunoensayo Elecsys AMH Plus (Roche Diagnostics, Basel, Suiza) para identificar la morfología del ovario poliquístico (PCOM), un criterio de síndrome de ovario poliquístico (PCOS). El estudio de la Proteína AMH en Humanos para Prueba Diagnóstica de la Morfología del Ovario Poliquístico fue un estudio retrospectivo, multicéntrico, caso-control. El nivel sérico de hormona antimülleriana (AMH) fue medido utilizando el inmunoensayo Elecsys AMH Plus. El conteo de folículos antrales fue determinado utilizando ecografía transvaginal. El punto de corte de AMH fue derivado y validado en cohortes separadas con casos de PCOS con fenotipo completo (oligo/ anovulación, hiperandrogenismo, y PCOM) versus co
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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. Not applicable. Polycystic ovary syndrome-positive (PCOS A–D per the Rotterdam criteria) and PCOS-negative women aged 25–45 years. None. A validated cutoff for AMH using the Elecsys AMH Plus assay for PCOM. 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. 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. Hormona antimülleriana para determinar la morfología del ovario poliquístico. Determinar un punto de corte para el inmunoensayo Elecsys AMH Plus (Roche Diagnostics, Basel, Suiza) para identificar la morfología del ovario poliquístico (PCOM), un criterio de síndrome de ovario poliquístico (PCOS). El estudio de la Proteína AMH en Humanos para Prueba Diagnóstica de la Morfología del Ovario Poliquístico fue un estudio retrospectivo, multicéntrico, caso-control. El nivel sérico de hormona antimülleriana (AMH) fue medido utilizando el inmunoensayo Elecsys AMH Plus. El conteo de folículos antrales fue determinado utilizando ecografía transvaginal. El punto de corte de AMH fue derivado y validado en cohortes separadas con casos de PCOS con fenotipo completo (oligo/ anovulación, hiperandrogenismo, y PCOM) versus controles. Se realizaron análisis exploratorios de edad y fenotipo PCOS. No aplica. Mujeres síndrome de ovario poliquístico-positivas (PCOS A-D por criterios de Rotterdam) y PCOS-negativas de 25-45 años. Ninguna. Un punto de corte validado para AMH utilizando el ensayo Elecsys AMH Plus para PCOM. En la cohorte de validación (455 casos y 500 controles) un punto de corte de AMH de 3.2 ng/mL (23 pmol/L) resultó en una sensibilidad de 88.6% (intervalo de confianza 95% [CI] 85.3-91.3) y una especificidad de 84.6% ( CI 95% 81.1-87.7) para el diagnóstico de PCOM así como un área bajo la curva característica operador-receptor de 93.6% (CI 95% 92.2-95.1). En mujeres de 25-35 años, la sensibilidad y especificidad para el punto de corte fueron 88.5% y 80.3%, respectivamente, versus 77.8% y 90.1%, respectivamente, en mujeres de 36-45 años. Los resultados fueron consistentes en los fenotipos PCOS A-D. 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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. Not applicable. Polycystic ovary syndrome-positive (PCOS A–D per the Rotterdam criteria) and PCOS-negative women aged 25–45 years. None. A validated cutoff for AMH using the Elecsys AMH Plus assay for PCOM. 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. 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. Hormona antimülleriana para determinar la morfología del ovario poliquístico. Determinar un punto de corte para el inmunoensayo Elecsys AMH Plus (Roche Diagnostics, Basel, Suiza) para identificar la morfología del ovario poliquístico (PCOM), un criterio de síndrome de ovario poliquístico (PCOS). El estudio de la Proteína AMH en Humanos para Prueba Diagnóstica de la Morfología del Ovario Poliquístico fue un estudio retrospectivo, multicéntrico, caso-control. El nivel sérico de hormona antimülleriana (AMH) fue medido utilizando el inmunoensayo Elecsys AMH Plus. El conteo de folículos antrales fue determinado utilizando ecografía transvaginal. El punto de corte de AMH fue derivado y validado en cohortes separadas con casos de PCOS con fenotipo completo (oligo/ anovulación, hiperandrogenismo, y PCOM) versus controles. Se realizaron análisis exploratorios de edad y fenotipo PCOS. No aplica. Mujeres síndrome de ovario poliquístico-positivas (PCOS A-D por criterios de Rotterdam) y PCOS-negativas de 25-45 años. Ninguna. Un punto de corte validado para AMH utilizando el ensayo Elecsys AMH Plus para PCOM. En la cohorte de validación (455 casos y 500 controles) un punto de corte de AMH de 3.2 ng/mL (23 pmol/L) resultó en una sensibilidad de 88.6% (intervalo de confianza 95% [CI] 85.3-91.3) y una especificidad de 84.6% ( CI 95% 81.1-87.7) para el diagnóstico de PCOM así como un área bajo la curva característica operador-receptor de 93.6% (CI 95% 92.2-95.1). En mujeres de 25-35 años, la sensibilidad y especificidad para el punto de corte fueron 88.5% y 80.3%, respectivamente, versus 77.8% y 90.1%, respectivamente, en mujeres de 36-45 años. Los resultados fueron consistentes en los fenotipos PCOS A-D. 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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. Not applicable. Polycystic ovary syndrome-positive (PCOS A–D per the Rotterdam criteria) and PCOS-negative women aged 25–45 years. None. A validated cutoff for AMH using the Elecsys AMH Plus assay for PCOM. 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. 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. Hormona antimülleriana para determinar la morfología del ovario poliquístico. Determinar un punto de corte para el inmunoensayo Elecsys AMH Plus (Roche Diagnostics, Basel, Suiza) para identificar la morfología del ovario poliquístico (PCOM), un criterio de síndrome de ovario poliquístico (PCOS). El estudio de la Proteína AMH en Humanos para Prueba Diagnóstica de la Morfología del Ovario Poliquístico fue un estudio retrospectivo, multicéntrico, caso-control. El nivel sérico de hormona antimülleriana (AMH) fue medido utilizando el inmunoensayo Elecsys AMH Plus. El conteo de folículos antrales fue determinado utilizando ecografía transvaginal. El punto de corte de AMH fue derivado y validado en cohortes separadas con casos de PCOS con fenotipo completo (oligo/ anovulación, hiperandrogenismo, y PCOM) versus controles. Se realizaron análisis exploratorios de edad y fenotipo PCOS. No aplica. Mujeres síndrome de ovario poliquístico-positivas (PCOS A-D por criterios de Rotterdam) y PCOS-negativas de 25-45 años. Ninguna. Un punto de corte validado para AMH utilizando el ensayo Elecsys AMH Plus para PCOM. En la cohorte de validación (455 casos y 500 controles) un punto de corte de AMH de 3.2 ng/mL (23 pmol/L) resultó en una sensibilidad de 88.6% (intervalo de confianza 95% [CI] 85.3-91.3) y una especificidad de 84.6% ( CI 95% 81.1-87.7) para el diagnóstico de PCOM así como un área bajo la curva característica operador-receptor de 93.6% (CI 95% 92.2-95.1). En mujeres de 25-35 años, la sensibilidad y especificidad para el punto de corte fueron 88.5% y 80.3%, respectivamente, versus 77.8% y 90.1%, respectivamente, en mujeres de 36-45 años. Los resultados fueron consistentes en los fenotipos PCOS A-D. El inmunoensayo Elecsys AMH Plus, con un punto de corte de 3.2 ng/mL (23 pmol/L), es un método robusto para identificar PCOM para ayudar en el diagnóstico de PCOS.</abstract><pub>Elsevier Inc</pub><doi>10.1016/j.fertnstert.2021.05.094</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-3245-9492</orcidid><oa>free_for_read</oa></addata></record>
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subjects Antimüllerian hormone
diagnosis
polycystic ovarian morphology
polycystic ovary syndrome
title Antimüllerian hormone to determine polycystic ovarian morphology
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