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Reference intervals for reproductive hormones in Chinese children aged 0-14 years based on the PRINCE study
Ying Liu1, Xiaoyi Tian1, Wenqi Song1
1Department of Clinical Laboratory Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, P.R. China.
Insights
This study established crucial age- and sex-specific reference intervals for reproductive hormones in Chinese children. These findings aid in monitoring child development and diagnosing paediatric endocrine disorders.
Area of Science:
- Pediatric Endocrinology
- Reproductive Health
- Clinical Chemistry
Background:
- Reproductive hormone concentrations fluctuate significantly during childhood and adolescence.
- Accurate age- and sex-specific reference intervals (RIs) are vital for assessing paediatric development.
- The Paediatric Reference Intervals in China (PRINCE) study provided data for this research.
Purpose of the Study:
- To establish and validate reference intervals (RIs) for key reproductive hormones in Chinese children.
- To provide age- and sex-specific data for hormones including luteinizing hormone, follicle-stimulating hormone, testosterone, oestradiol, progesterone, and prolactin.
- To support the interpretation of laboratory results and clinical standards for paediatric endocrine disorders.
Main Methods:
- Utilized data from 1,707 healthy children (819 males, 888 females) from the PRINCE cohort.
- Determined age- and sex-specific RIs for six reproductive hormones using a non-parametric method.
- Validated the established RIs using an independent set of 280 samples.
Main Results:
- Established paediatric RIs for luteinizing hormone, follicle-stimulating hormone, testosterone, oestradiol, progesterone, and prolactin.
- Identified key hormonal surges during pubertal transition in both sexes.
- Demonstrated stable prolactin levels from ages 1-14 and increased progesterone in females after age 11.
Conclusions:
- This study presents the first validated RIs for reproductive hormones in Chinese children aged 0-14 years.
- Provides essential evidence-based data for clinical interpretation and diagnosis of paediatric endocrine conditions.
- Establishes a foundation for clinical standards in paediatric endocrinology within China.
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.

