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A multicenter study on the clinical application value of novel reproductive hormones in children with central precocious puberty

A multicenter study on the clinical application value of novel reproductive hormones in children with central precocious puberty

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117372
Enrollment
Unknown
Registered
2026-01-23
Start date
2024-07-05
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central precocious puberty

Interventions

Case group:Not involved
Control Group:Not involved

Sponsors

Capital Center For Children’s Health, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Boys <12.0 years old, girls <11.0 years old, Han Chinese children; 2.Newly diagnosed children with CPP according to the "Consensus on Diagnosis and Treatment of Central Precocious Puberty (2022)"; 3.No treatment that may affect the sex hormones levels within one year; 4. The legal guardians of all participants must sign the informed consent form. Participants who are 8 years old or above must also sign the informed consent form themselves. Control group: 1. Age 0-18 years, Han ethnicity children; 2. No signs of precocious puberty (i.e., girls showing breast development before 7.5 years old or menarche before 10 years old, boys showing testicular enlargement before 9 years old), bone age within +/-1 year of actual age; 3. No treatments potentially affecting hormone levels (including hormones, traditional Chinese medicine, surgery, etc.) in the past year; 4. The legal guardians of all subjects must sign the informed consent form, and subjects aged 8 years or older must also sign the informed consent form themselves.

Exclusion criteria

Exclusion criteria: 1.Obese children diagnosed according to the Definition and Prevention Recommendations of Metabolic Syndrome in Chinese Children and Adolescents. 2.Children diagnosed with peripheral precocious puberty, incomplete precocious puberty, delayed sexual development, abnormal sexual differentiation and other abnormalities of sexual development. 3.Children diagnosed with endocrine diseases such as congenital hypothyroidism, congenital adrenocortical hyperplasia, adrenal tumors, hypothalamic-pituitary tumors, etc. 4.Children with other acute and chronic diseases. 5.Samples with unknown or missing sample information, hemolysis, lipemia, remaining serum and/or morning urine samples with insufficient volume to complete the test. 6.The children and guardian have refused or failed to sign informed consent form.

Design outcomes

Primary

MeasureTime frame
Serum anti-Müllerian hormone (AMH);Serum inhibin A (INHA);Serum inhibin B (INHB);Urinary Luteinizing hormone(LH);

Secondary

MeasureTime frame
Serum Progesterone(P);Serum Testosterone(T);Serum Estradiol(E2);Serum Luteinizing hormone(LH);Serum Follicle stimulating hormone(FSH);Serum Prolactin(PRL);

Countries

China

Contacts

Public ContactLijuan Ma

Capital Center For Children’s Health, Capital Medical University

malijuan@shouer.com.cn+86 10 85695362

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026