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Evaluation of the correlation between various treatment modalities and adolescent polycystic ovary syndrome in girls with central precocious puberty or early and fast puberty: An open-label, observational, two-way cohort study

Evaluation of the correlation between various treatment modalities and adolescent polycystic ovary syndrome in girls with central precocious puberty or early and fast puberty: An open-label, observational, two-way cohort study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099277
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-03-24
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

PCOS: The 2018 Guidelines for the Diagnosis and Treatment of Polycystic Ovary Syndrome in China define the diagnostic criteria for adolescent PCOS, which include the following four conditions: 1) oligomenorrhea after menarche lasting at least 2 years or amenorrhea

Interventions

Group treated with GnRHa:None
Observation group:None
Group treated with GnRHa and rhGH:None

Sponsors

Suzhou Science & Technology Town Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Consistent with the diagnosis of CPP or EFP. (1) CPP: 1) Girls with breast development before 7.5 years old or menarche before 10 years old; 2) Linear growth or sexual development in Tanner stage were accelerated , and the advancement of bone age exceeds >= 1 year the chronological age; 3) Pelvic B-ultrasound revealed the enlargement of ovarian with volume > 1 ml (ovarian volume = length × width × thickness × 0.5233) or multiple follicle? with diameter >= 4 mm; 4) LH peak value from GnRH stimulation >= 5.0 U/L and the LH to FSH peak value ratio >= 0.6;  (2) EFP: 1) Girls with breast development between 8 to 10 years old; 2) Type with rapid progresion (characterized by rapid sexual development, less than 6 months to advance to the next stage; Within a brief period Swift advancement of skeletal maturation, with a significant discrepancy over chronological age); 3) Linear growth or sexual development in Tanner stage were accelerated , and the advancement of bone age exceeds >= 1 year the chronological age; 4) Pelvic B-ultrasound revealed the enlargement of ovarian with volume > 1 ml (ovarian volume = length × width × thickness × 0.5233) or multiple follicle? with diameter >= 4 mm; 5) LH peak value from GnRH stimulation >= 5.0 U/L and the LH to FSH peak value ratio >= 0.6; 2.Adrenocortical hyperplasia, hypothyroidism, Cushing's syndrome, androgen-secreting tumors, and other related endocrine diseases were excluded; 3.The medication group's treatment course should be at least one year; 4.Parents were informed and gave their consent to participate in the study;

Exclusion criteria

Exclusion criteria: 1.Serious systemic diseases and long-term chronic drug treatment; 2.Use of other hormone drugs within the past six months; 3.Any other condition deemed inappropriate for inclusion in the study by the investigator;

Design outcomes

Primary

MeasureTime frame
Incidence of PCOS;

Secondary

MeasureTime frame
Sexual development indicators, growth-related indicators, metabolic indicators.;Liver and kidney function, thyroid function, insulin-like growth factor-1 (IGF-1), incidence of adverse events (AEs) and serious adverse events (SAEs).;

Countries

China

Contacts

Public Contactzhimin ma

Suzhou Science & Technology Town Hospital

Mazhimin01@sina.com+86 134 5168 8205

Outcome results

None listed

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