Multicenter analytical performance evaluation of a fully automated anti-Müllerian hormone assay and reference interval determination

Anckaert, Ellen; Öktem, M.; Thies, A.; Cohen-Bacrie, M.; Daan, Nadine M.P.; Schiettecatte, Johan; Müller, Christian; Topçu, Deniz İlhan; Gröning, A.; Ternaux, F; Engel, Christine; Engelmann, S.; Milczynski, Christoph

doi:10.1016/j.clinbiochem.2015.10.008

Cited by 85 publications

(76 citation statements)

References 31 publications

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“…In contrast, follitropin delta dosing has been linked with the Roche Elecsys ® AMH immunoassay as the companion diagnostic that was validated in the phase 3 ESTHER‐1 registration study . In the current study, assay variability was 2.5%‐3.5%, which is comparable to published data for the same assay and the automated Beckman Coulter Access AMH assay . Biological variability is therefore likely to have been the main contributor to the total variability.…”

Section: Discussionsupporting

confidence: 70%

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Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

Nelson

Mannaerts

Andersen

et al. 2019

Clinical Endocrinology

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Summary Objective The stability of anti‐Müllerian hormone (AMH) across and between menstrual cycles has been the subject of debate. The objective of this analysis was to study the inter‐ and intracycle variability in repeated measurements and assess the impact on an individualized gonadotropin dosing algorithm and predicted oocyte yield. Design Retrospective analysis of repeat AMH measures from a randomized controlled trial. Patients A total of 1326 women aged 18‐40 years. Measurements Serum AMH levels at screening and at cycle day 2‐3 in up to three ovarian stimulation cycles. AMH variability and its impact on gonadotropin dose and the predicted number of oocytes. Results Repeat serum AMH measurements were strongly correlated within individual women (correlation coefficient 0.92). AMH exhibited limited within‐subject variation (coefficient of variation 23%), a small time‐related decline (mean 6% decrease/y), but no systematic variation across the menstrual cycle. Irrespective of whether the AMH screening value or the AMH at the initiation of ovarian stimulation was used, for women with an AMH level <15 pmol/L, 93% would receive the same gonadotropin dose and attain an identical number of oocytes in 97% of cases. For women with an AMH level ≥15 pmol/L, 80% would receive an individualized dose within ±1.5 μg and 90% would attain ±1 oocyte. Conclusion AMH variability had limited impact on individualized gonadotropin dosing, with 95% of women predicted to obtain an oocyte yield that does not vary beyond 1 oocyte count, irrespective of whether a random or early follicular AMH measurement was used to determine the individualized gonadotropin dose.

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Section: Discussionsupporting

confidence: 70%

“…Serum AMH levels were examined across the menstrual cycle, with multiple measurements available for each day to determine whether there was any substantial variation related to follicular development, ovulation or the luteal phase. In addition, the study used a validated automated AMH immunoassay with minimal variability …”

Section: Discussionmentioning

confidence: 99%

Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

Nelson

Mannaerts

Andersen

et al. 2019

Clinical Endocrinology

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“…Thereafter, the levels begin to decline with an inverse correlation between age and AMH, as the ovarian reserve is progressively depleted . Median AMH is 4 ng/mL in normally ovulating women aged 20–24 years . Although interindividual differences exist at any given age, serum AMH is stable throughout the menstrual cycle and is unaffected by medication.…”

Section: Discussionmentioning

confidence: 99%

Assessment of ovarian reserve using serum anti‐Müllerian hormone after ovarian torsion surgery

Oskaylı

Gulcin

Ozatman

et al. 2019

Pediatrics International

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Background The aim of this study was to determine ovarian reserve using serum anti‐Müllerian hormone (AMH) level in children who had undergone either ovarian‐preserving surgery or oophorectomy because of ovarian torsion. Methods Patients aged > 10 years who had undergone surgery for unilateral ovarian torsion were contacted for the study with ethics committee approval. Seventeen patients agreed to be included. Results A total of 10 patients had undergone ovarian detorsion and seven had undergone oophorectomy. Mean age at operation was 11.6 ± 2.23 years (range, 8–15 years) and 13.2 ± 2.17 years (range, 10–16 years), respectively (P = 0.46). Ovarian torsion was isolated in four patients in the first group, and in three in the second. The remainder had associated benign masses. At the time of this study, mean patient age was 18 ± 2.11 years (range, 14–21 years) with a mean postoperative follow up of 5.9 ± 2.8 years (range, 2–10.5 years). Echogenicity of all preserved ovaries was normal on pelvic Doppler ultrasonography, with presence of antral follicles in six. Three ovaries were smaller than expected for age, although two of these had antral follicles. Mean AMH was 5.54 ± 2.25 ng/mL in the detorsion group and 2.70 ± 2.11 ng/mL in the oophorectomy group (P = 0.04). Conclusions The presence of follicles in preserved ovaries after detorsion has been reported previously. AMH is expressed in granulosa cells of growing follicles and its serum level is valuable in assessing the quantitative aspects of ovarian reserve. Preservation of the ovary in children with torsion is justified in terms of future ovarian reserve.

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“…The assay is correlated to AFC. It is a reliable assay with lower coefficient of variation (CV)% ≤1.8% for repeatability, ≤4.4% for intermediate precision with a very sensitive measurement range of 0.01–23 ng/mL …”

Section: Methodsmentioning

confidence: 99%

Ovarian reserve after internal iliac artery ligation

Mathyk

Çetin

Atakul³

et al. 2018

J of Obstet and Gynaecol

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Multicenter analytical performance evaluation of a fully automated anti-Müllerian hormone assay and reference interval determination

Abstract: The Elecsys® AMH assay demonstrated good precision under routine conditions, and is suitable for determining AMH levels in serum and lithium-heparin plasma.

Cited by 85 publications

References 31 publications

Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

Assessment of ovarian reserve using serum anti‐Müllerian hormone after ovarian torsion surgery

Ovarian reserve after internal iliac artery ligation

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