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Clinical Trials in Italy / NCT07859787
Recruiting Observational

INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty

NCT07859787 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2026-10-02
Last updated
2026-10-06

Condition(s) studied

Precocious Puberty, CentralDelayed Puberty

Study summary

This is an observational study in children up to 16 years old who are suspected of having central precocious puberty or delayed puberty. The main questions it aims to answer are:

* Can the level of insulin-like peptide 3 (INSL3) predict if a child's puberty has truly started?
* Can this marker help reduce the need for more complex and invasive tests?

Participants will:

* Give one extra blood sample just before starting the standard gonadotropin-releasing hormone (GnRH) stimulation test (during the baseline blood draw).
* Have this extra sample used to measure the INSL3 hormone.
* Complete the rest of the GnRH test as prescribed by their doctor.

Researchers will compare the INSL3 hormone levels in children who have a positive GnRH test to those who have a negative test. This will help researchers learn if INSL3 can be used as a new, simple tool to diagnose early or delayed puberty.

Eligibility

Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 0 and 16 years at the time of enrollment. * Males with suspected Central Precocious Puberty (CPP), defined by a testicular volume ≥4 mL before 9 years of age. * Females with suspected CPP, defined by the onset of thelarche before 8 years of age. * Males with suspected Delayed Puberty (DP), defined by testicular volume \<4 mL by 14 years of age. * Females with suspected DP, defined by the absence of thelarche by 13 years of age. * Written informed consent for study participation and personal data processing provided by the parents/legal guardians, with the assent of the participating minor. Exclusion Criteria: * Presence of congenital or acquired conditions known to primarily alter pubertal development or gonadal function, regardless of HPG axis physiology (e.g., disorders of sex development, anorchia, previous ovariectomy, uncorrected bilateral cryptorchidism, previous iatrogenic gonadotoxicity). * Primary endocrine diseases interfering with hypothalamic-pituitary-gonadal axis regulation (e.g., congenital hypogonadotropic hypogonadism, panhypopituitarism). * Use of hormonal therapies or drugs capable of modifying gonadal function or the response to the GnRH test (e.g., exogenous sex steroids, androgens/anabolic steroids).

Primary outcome measure(s)

  • Baseline INSL3 Concentration as a Predictor of GnRH Test Outcome — Baseline (prior to GnRH test administration)
    Assessment of baseline Insulin-like peptide 3 (INSL3) levels (measured in pg/ml) and their association with the gonadotropin response to the standard GnRH stimulation test (evaluated by peak LH, peak FSH in mU/ml, and LH/FSH ratio) to determine Hypothalamic-Pituitary-Gonadal (HPG) axis activation in patients with suspected precocious or delayed puberty.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Bologna 40138 Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07859787 on ClinicalTrials.gov ↗ ← All trials in Italy