Actively Recruiting

Age: 0 - 45Years
FEMALE
NCT07461519

Gonadic Function and Pubertal Development in Female Patients With Classic Galactosemia

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-03-10

60

Participants Needed

19

Research Sites

915 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Newborn screening and a galactose-free diet have improved early outcomes in galactosemia, but long-term issues such as primary ovarian insufficiency (POI) remain significant. This study aims to clarify clinical, hormonal, developmental, and fertility-related factors in affected girls through a large multicenter Italian cohort.

CONDITIONS

Official Title

Gonadic Function and Pubertal Development in Female Patients With Classic Galactosemia

Who Can Participate

Age: 0 - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients followed at Pediatric Endocrinology and Inherited Metabolic Disease Centers
  • Born between January 1, 1980 and December 31, 2024
  • Diagnosis of classic galactosemia confirmed by genetic testing
  • Informed consent obtained
Not Eligible

You will not qualify if you...

  • Known chromosomal abnormalities such as trisomy 21, Turner syndrome, Fragile X syndrome, Kabuki syndrome, or other genetic conditions linked to pubertal disorders
  • Primary ovarian insufficiency caused by conditions other than galactosemia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

SSD Nutrizione Clinica e Metabolismo - IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, Italy, 40138

Actively Recruiting

2

UOC Pediatria - IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, Italy, 40138

Actively Recruiting

3

Ospedale Pediatrico "Giovanni XXIII"

Bari, Italy

Not Yet Recruiting

4

Ospedale Pediatrico Microcitemico "A. Cao"

Cagliari, Italy

Not Yet Recruiting

5

AOU Policlinico di Catania

Catania, Italy

Not Yet Recruiting

6

AOU "Dulbecco", Policlinico Germaneto-Università di Catanzaro

Catanzaro, Italy

Not Yet Recruiting

7

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Italy

Actively Recruiting

8

IRCCS Istituto G. Gaslini

Genova, Italy

Actively Recruiting

9

AOU Policlinico G. Martino

Messina, Italy

Not Yet Recruiting

10

ASST Santi Paolo e Carlo - Presidio San Paolo - Università degli studi di Milano

Milan, Italy

Not Yet Recruiting

11

Ospedale dei Bambini "Vittore Buzzi"

Milan, Italy

Not Yet Recruiting

12

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Actively Recruiting

13

AORN Santobono Pausilipon

Naples, Italy

Not Yet Recruiting

14

Azienda Ospedaliera Universitaria "Federico II"

Naples, Italy

Not Yet Recruiting

15

Azienda Ospedale-Università di Padova

Padova, Italy

Not Yet Recruiting

16

Ospedale dei Bambini di Palermo

Palermo, Italy

Not Yet Recruiting

17

Ospedale Guglielmo da Saliceto

Piacenza, Italy

Actively Recruiting

18

Ospedale Pediatrico Bambin Gesù IRCCS

Roma, Italy

Actively Recruiting

19

Ospedale Infantile Regina Margherita, AOU Città della Salute e della Scienza di Torino

Torino, Italy

Not Yet Recruiting

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Research Team

R

Rita Ortolano

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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