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The application of antimullerian hormone level in central precocious puberty diagnosis by single molecule immunology technique

The application of antimullerian hormone level in central precocious puberty diagnosis by single molecule immunology technique

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076352
Enrollment
Unknown
Registered
2023-10-06
Start date
2023-10-06
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

precocious puberty

Interventions

Gold Standard:GnRH stimulation test
Index test:AMH in peripheral blood/capillary blood/urine

Sponsors

Shanghai Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
5 Years to 9 Years

Inclusion criteria

Inclusion criteria: ? GnRH dependent precocious puberty (CPP) group: 1) Female, age 5~9 years old; 2) Secondary sexual characteristics before 7.5 years of age or menarche before 10 years of age; 3) Bone age - age > 1 year; 4)GnRH stimulation test: LH peak =5IU/L and LH peak /FSH peak =0.6; 5) Sign informed consent. ? GnRH independent precocious puberty group: 1) Female, age 5~9 years old; 2) Secondary sexual characteristics before 7.5 years of age or menarche before 10 years of age; 3)GnRH stimulation test: LH peak < 5IU/L or LH peak /FSH peak < 0.6; 4) Sign informed consent.

Exclusion criteria

Exclusion criteria: Anyone who meets any of the following criteria should not participate in the study: 1) Patients with chronic diseases such as malignant tumors, tuberculosis, other endocrine diseases, acute/chronic infections, blood diseases, mental disorders, autoimmune diseases, and digestive disorders; 2) The patient had severe arrhythmia, congenital heart disease/cardiomyopathy, and cardiac insufficiency (NYHA grade ?/?); 3) The patient has significant liver disease (ALT or AST above 2 times the upper limit of normal); 4) The patient has significant renal impairment, defined as creatinine =110 µmol/L (or =1.3 mg/dL); 5) Patients take drugs that affect metabolism, such as glucocorticoids, thyroxine, growth hormone, etc.; 6) Known or suspected to cause serious discomfort to the test operation or related auxiliary examination; 7) Is participating in another clinical investigator.

Design outcomes

Primary

MeasureTime frame
AMH;

Secondary

MeasureTime frame
Accuracy;Sensitivity;Specificity;Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactXIUMIN WANG

Shanghai Children's Medical Center

wangxiumin1019@126.com+86 180 1739 5221

Outcome results

None listed

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