Clinical trial NCT06720623: Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty
Official title: Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Precocious Puberty (CPP)
Keywords: Central Precocious Puberty
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 213
Sex: FEMALE
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: LH value
timeFrame: at baseline
Secondary outcomes:
measure: Uterine volume
timeFrame: at baseline
measure: Longitudinal uterine diameter
timeFrame: at baseline
measure: Presence of endometrial rhyme
timeFrame: at baseline
measure: Ratio of peak LH/FSH values
timeFrame: at baseline
measure: peak LH (mU/mL) value / FSH value ( mU/mL)
timeFrame: at baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Federico Baronio, MD
role: PRINCIPAL_INVESTIGATOR
References: