Reference intervals for reproductive hormones in Chinese children aged 0–14 years based on the PRINCE study

BACKGROUND: The concentrations of reproductive hormones considerably change during growth and development. Establishing accurate age- and sex-specific reference intervals for these hormones is important for monitoring development during childhood. Therefore, this study used data from the Paediatric Reference Intervals in China (PRINCE) study to establish and validate reference intervals (RIs) for sex and reproductive hormones in Chinese children. MATERIALS AND METHODS: This study is based on healthy children and adolescents from the PRINCE cohort. Serum samples were collected to determine age- and sex-specific RIs for luteinizing hormone, follicle-stimulating hormone, testosterone, oestradiol, progesterone and prolactin using a non-parametric method recommended by the Clinical and Laboratory Standards Institute guidelines. RESULTS: The study included 1,707 healthy children (819 males and 888 females). Paediatric RIs for six reproductive hormones were established and stratified into distinct age and sex partitions. Key hormonal surges marked pubertal transition: in females, the upper limit of oestradiol more than doubled at age 9 years, while follicle-stimulating hormone began rising at age 8 years. In males, the upper limit of testosterone increased several-fold at age 11 years. Luteinizing hormone rose from age 9 in both sexes. Prolactin remained stable from ages 1-14, while progesterone increased in females after age 11. The RIs were successfully validated in 280 samples. CONCLUSION: This study is the first to establish and validate RIs for sex and reproductive hormones in Chinese children aged 0-14 years, thereby providing evidence-based support for interpreting laboratory test results and establishing clinical standards for paediatric endocrine disorders.