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Validation, normative data and clinical utility of an enzymeimmunoassay for anti-Müllerian serum measurement

Abstract

The anti-Mullerian hormone (AMH - Anti-Mullerian hormone) is a dimeric glycoprotein that belongs to the family of TGF-². In males, AMH is produced by Sertoli cells, has the role of promoting the regression of the Mullerian duct and acts in the development and gonadal function. Physiologically, the male AMH is elevated during the pre-pubertal and declines in early puberty remains low during adulthood. In females the absence of AMH in the embryo allows the differentiation of Mullerian duct to form the uterus, fallopian tubes and upper third of the vagina. In women, AMH is synthesized by granulosa cells is undetectable at birth reaches peak during the reproductive phase and gradually declines with advancing age. Since AMH represents a marker of ovarian and testicular function, the validation of a commercial enzyme immunoassay for AMH assessment is of fundamental importance. In addition, to establish normative values in Brazilian males and females for the clinical applicability in different pathological situations is necessary. Our primary goal is to validate a new AMH GenII immunosorbent assay (Beckman Coulter, Inc., Webster, Texas) for serum measurement of AMH and as secondary endpoint to determine the clinical applicability in distinct pathological conditions, since several patients in whom AMH measurement can be useful are followed at the Unit of Developmental Endocrinology (Hospital das Clínicas da Universidade de Sao Paulo, Brazil). (AU)