Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06720623

Enrollment

213

Registered

2024-12-06

Start date

2021-05-25

Completion date

2023-12-31

Last updated

2024-12-06

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

Conditions

Central Precocious Puberty (CPP)

Keywords

Central Precocious Puberty

Brief summary

This is an observational, retrospective, single-center study focused on the diagnosis of Central Precocious Puberty in female patients.

Detailed description

The study enrolls female patients undergoing GnRh testing for suspected diagnosis of Central Early Puberty between january 2017 and December 2020 at the Pediatrics Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola. The study design provides 2 cohorts of female patients on the basis of the LH peak value in GnRH test: patients with LH peak value \< 5U/L, and patients with LH peak value \> 5U/L. The primary aim is to assess the diagnostic power of basal LH comparing with the LH peak value after stimulus test with GnRH in female patients with suspected precocious puberty. The secondary aim is to assess the association of the following variables between the two cohorts: uterine volume, longitudinal uterine diameter, presence of endometrial rhyme, ratio of peak LH/FSH values and dose per kg of GnRH administered during stimulus test.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 8 Years

Healthy volunteers

Inclusion criteria

* Female patients with onset of signs of early pubertal development (onset of telarche) before the age of 8 years, who referred to the Pediatrics Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola between January 2017 and December 2020; * Female patients undergoing GnRh testing for suspected diagnosis of Central Early Puberty between january 2017 and December 2020; * Obtaining informed consent from parents/legal guardian of pediatric patients.

Exclusion criteria

• Patients with Peripheral precocious puberty.

Design outcomes

Primary

Measure	Time frame	Description
LH value	at baseline	basal Lh value, and LH peak value after stimulus test with GnRH (mU/mL )

Secondary

Measure	Time frame	Description
Uterine volume	at baseline	ml
Longitudinal uterine diameter	at baseline	mm
Presence of endometrial rhyme	at baseline	yes/no
Ratio of peak LH/FSH values	at baseline	peak LH (mU/mL) value / FSH value ( mU/mL)
peak LH (mU/mL) value / FSH value ( mU/mL)	at baseline	mcg/kg

Countries

Italy

Outcome results