The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-Platforms

This study examined longitudinal, age-related and intra-individual variation in Anti-Müllerian Hormone (AMH) in regular menstruating women and correlated the hormonal levels to the antral follicle count (AFC). The impact of variations on an algorithm for calculation of follitropin-dose for ovarian s...

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Main Authors: Leif Bungum, Julia Tagevi, Ligita Jokubkiene, Mona Bungum, Aleksander Giwercman, Nick Macklon, Claus Yding Andersen, Tobias Wirenfeldt Klausen, Niels Tørring, Ajay Kumar, Sven Olaf Skouby
Format: Article
Language:English
Published: Frontiers Media S.A. 2018-10-01
Series:Frontiers in Endocrinology
Subjects:
Online Access:https://www.frontiersin.org/article/10.3389/fendo.2018.00603/full
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spelling doaj-f09e05ff3277420ba41b15e03697fbec2020-11-24T22:50:38ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922018-10-01910.3389/fendo.2018.00603394307The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-PlatformsLeif Bungum0Julia Tagevi1Ligita Jokubkiene2Mona Bungum3Aleksander Giwercman4Nick Macklon5Claus Yding Andersen6Tobias Wirenfeldt Klausen7Niels Tørring8Ajay Kumar9Sven Olaf Skouby10Department of Obstetrics and Gynecology, Herlev Gentofte Hospital, Herlev, DenmarkDepartment of Translational Medicine, Lund University, Lund, SwedenDepartment of Obstetrics and Gynecology, Skåne University Hospital, Malmø, SwedenReproductive Medicine Centre, Skanes University Hospital, Malmø, SwedenReproductive Medicine Centre, Skanes University Hospital, Malmø, SwedenObsterics and Gynecology, Denmark and London Women's Clinic, Zealand University Hospital, London, United KingdomLaboratory of Reproductive Biology, Copenhagen University Hospital, Copenhagen, DenmarkDepartment of Obstetrics and Gynecology, Herlev Gentofte Hospital, Herlev, DenmarkDepartment of Clinical Biochemistry, Aarhus University Hospital, Aarhus, DenmarkAnsh Labs LLC, Medical Center Blvd, Webster, IA, United StatesDepartment of Obstetrics and Gynecology, Herlev Gentofte Hospital, Herlev, DenmarkThis study examined longitudinal, age-related and intra-individual variation in Anti-Müllerian Hormone (AMH) in regular menstruating women and correlated the hormonal levels to the antral follicle count (AFC). The impact of variations on an algorithm for calculation of follitropin-dose for ovarian stimulation were also tested. The study was carried out at a fertility clinic of a tertiary university hospital and had a prospective trial design. Twenty-six healthy women not receiving infertility treatment aged 22 to 50 years participated. Blood sampling for hormonal analysis was done every fifth day throughout three consecutive menstrual cycles, AFC was determined with 3-dimentional ultrasound and AMH measured by different assays from Beckman Coulter, Roche and Ansh Labs. Outcome measures were maximum and minimum difference in absolute and relative terms for each study subject during the test-period, coefficient of variation (Cv) for AMH for each cycle and cycle-day and correlation between AMH and AFC. The impact from variable AMH levels on an algorithm calculating follitrophin-delta dose in ovarian stimulation was explored. A significant longitudinal age-independent variation in AMH-levels and coefficient of variation in cycles and cycle days was found. A strong correlation between AMH-levels and AFC was confirmed and a case of significant divergence between assays was seen. Variations in AMH had a significant impact on an algorithm calculated dosage of gonadotrophins in ovarian stimulation. The finding of a substantial longitudinal variation in AMH question one recording being sufficient in quantifying gonadotrophins for ovarian stimulation, decision making and prognostication related to infertility treatment and counseling. Occasionally, commercial assays may fail to recognize specific AMH cleavage-products.https://www.frontiersin.org/article/10.3389/fendo.2018.00603/fullanti mullerian hormoneantral follicle countbiomarkersinfertility counselingfemale infertility
collection DOAJ
language English
format Article
sources DOAJ
author Leif Bungum
Julia Tagevi
Ligita Jokubkiene
Mona Bungum
Aleksander Giwercman
Nick Macklon
Claus Yding Andersen
Tobias Wirenfeldt Klausen
Niels Tørring
Ajay Kumar
Sven Olaf Skouby
spellingShingle Leif Bungum
Julia Tagevi
Ligita Jokubkiene
Mona Bungum
Aleksander Giwercman
Nick Macklon
Claus Yding Andersen
Tobias Wirenfeldt Klausen
Niels Tørring
Ajay Kumar
Sven Olaf Skouby
The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-Platforms
Frontiers in Endocrinology
anti mullerian hormone
antral follicle count
biomarkers
infertility counseling
female infertility
author_facet Leif Bungum
Julia Tagevi
Ligita Jokubkiene
Mona Bungum
Aleksander Giwercman
Nick Macklon
Claus Yding Andersen
Tobias Wirenfeldt Klausen
Niels Tørring
Ajay Kumar
Sven Olaf Skouby
author_sort Leif Bungum
title The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-Platforms
title_short The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-Platforms
title_full The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-Platforms
title_fullStr The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-Platforms
title_full_unstemmed The Impact of the Biological Variability or Assay Performance on AMH Measurements: A Prospective Cohort Study With AMH Tested on Three Analytical Assay-Platforms
title_sort impact of the biological variability or assay performance on amh measurements: a prospective cohort study with amh tested on three analytical assay-platforms
publisher Frontiers Media S.A.
series Frontiers in Endocrinology
issn 1664-2392
publishDate 2018-10-01
description This study examined longitudinal, age-related and intra-individual variation in Anti-Müllerian Hormone (AMH) in regular menstruating women and correlated the hormonal levels to the antral follicle count (AFC). The impact of variations on an algorithm for calculation of follitropin-dose for ovarian stimulation were also tested. The study was carried out at a fertility clinic of a tertiary university hospital and had a prospective trial design. Twenty-six healthy women not receiving infertility treatment aged 22 to 50 years participated. Blood sampling for hormonal analysis was done every fifth day throughout three consecutive menstrual cycles, AFC was determined with 3-dimentional ultrasound and AMH measured by different assays from Beckman Coulter, Roche and Ansh Labs. Outcome measures were maximum and minimum difference in absolute and relative terms for each study subject during the test-period, coefficient of variation (Cv) for AMH for each cycle and cycle-day and correlation between AMH and AFC. The impact from variable AMH levels on an algorithm calculating follitrophin-delta dose in ovarian stimulation was explored. A significant longitudinal age-independent variation in AMH-levels and coefficient of variation in cycles and cycle days was found. A strong correlation between AMH-levels and AFC was confirmed and a case of significant divergence between assays was seen. Variations in AMH had a significant impact on an algorithm calculated dosage of gonadotrophins in ovarian stimulation. The finding of a substantial longitudinal variation in AMH question one recording being sufficient in quantifying gonadotrophins for ovarian stimulation, decision making and prognostication related to infertility treatment and counseling. Occasionally, commercial assays may fail to recognize specific AMH cleavage-products.
topic anti mullerian hormone
antral follicle count
biomarkers
infertility counseling
female infertility
url https://www.frontiersin.org/article/10.3389/fendo.2018.00603/full
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