Age- and sex-specific reference intervals for anti-Müllerian hormone during childhood in Chinese population: a cross-sectional study of 2,450 healthy children.

Background: Anti-Müllerian hormone (AMH) serves as a reliable biomarker of testicular function in males and ovarian function in females. However, reference intervals (RIs) for AMH in Chinese pediatric populations are scarce. This study aimed to establish age- and sex-specific RIs for AMH in healthy Chinese children and explore its correlation with six sex hormones.

Methods: A cross-sectional study conducted from September 2022 to August 2023 recruited 2,450 healthy participants aged 1 day-19 years. Serum AMH levels were measured using the CL-6000i automated chemiluminescence immunoassay analyzer (Mindray, Shenzhen, China). RIs were established following Clinical and Laboratory Standards Institute (CLSI) guidelines and were defined according to the nonparametric median (P50), the 2.5th (P2.5) and 97.5th (P97.5) percentiles and 95% interval range (P2.5-P97.5).

Results: In males, serum AMH levels were high at birth [1 d-1 m: 46.49 (2.89, 120.15) ng/mL], increased markedly from 1 to 12 months [94.75 (0.49, 248.73) ng/mL], and then continuously declined until 18 years of age [15-18 years: 5.33 (0.83, 13.72) ng/mL)], followed by a slight increase between 18 and 19 years of age [6.79 (2.22, 17.32) ng/mL]. In females, serum AMH levels were low within the first month after birth [0.27 (0.01, 88.7) ng/mL], gradually increased thereafter, peaked at 9 years of age [1 m-9 y: 2.32 (0.45, 103.99) ng/mL], underwent a slight decline between 9 and 15 years [2.49 (0.51, 60.00) ng/mL], and reached a plateau from 15 to 19 years [3.44 (1.13, 10.32) ng/mL]. Age- and sex-specific RIs for AMH were determined. There were four age-specific RIs in males including 1 day-1 month (P50 46.49 ng/mL; 95% interval range, 2.89-120.15 ng/mL), >1 month-3 years (P50 92.20 ng/mL; 95% interval range, 1.05-232.77 ng/mL), >3-12 years (P50 44.97 ng/mL; 95% interval range, 1.50-121.97 ng/mL), and >12-19 years (P50 6.23 ng/mL; 95% interval range, 1.94-16.14 ng/mL). Similarly, there were four age-specific RIs in females, including1 day-1 month (P50 0.27 ng/mL; 95% interval range, 0.01-88.7 ng/mL), >1 month-9 years (P50 2.32 ng/mL; 95% interval range, 0.45-103.99 ng/mL), >9-15 years (P50 2.49 ng/mL; 95% interval range, 0.51-60.00 ng/mL), and >15-19 years (P50 3.44 ng/mL; 95% interval range, 1.13-10.32 ng/mL).

Conclusions: In this study, we established age- and sex-specific serum AMH RIs using the Mindray CL-6000i system in healthy children in Wuhan, China. AMH exhibits significant fluctuations across the various stages of growth and development in both genders. This will aid in providing clinicians with a decision-making tool and broaden its application in pediatric care.