NCT07288762

Brief Summary

Patient with transfusion depandant beta thalassemia with accumulation of iron in their body affect pituitary gland and gonades lead to impaired their functions .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Dec 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Dec 2025Aug 2026

First Submitted

Initial submission to the registry

November 22, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

December 7, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

December 17, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

November 22, 2025

Last Update Submit

December 4, 2025

Conditions

Thalassemia Majors (Beta-Thalassemia Major)

Keywords

INSL3 or inhibin B hormone in transfusion depandant beta thalassemia

Outcome Measures

Primary Outcomes (1)

  • gonadal function in transfusion depandant beta thalassemia

    gonadal function assessment by Inhibin B hormone, INSL3 , serum testesterone that analysed in patient with age 10 - 18 year old for early detection of any abnormality

    through study completion, an average of 1 year

Study Arms (1)

group 1 transfusion depandant beta thalassemia

transfusion depandant beta thalassemia 10 - 18 years old age gonadal function assesment

Diagnostic Test: serum inhibin B serum INSL3 serum AMH

Interventions

serum inhibin B serum INSL3 serum AMHDIAGNOSTIC_TEST

transfusion depandant beta thalassemia with measure gonadal function serum INSL3 serum inhibin B serum AMH

group 1 transfusion depandant beta thalassemia

Eligibility Criteria

Age10 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

transfusion depandant beta thalassemia male patients age 10 - 18 year old age

You may qualify if:

  • transfusion depandant beta thalassemia
  • age 10 to 18 year old age

You may not qualify if:

  • age below 10 year old age or above 18 year old age
  • associated with another disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • hager Saadeldin, resident

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hager Saadeldin saadeldin, pediatric resident

CONTACT

+201065099621hagersaadeldin@gmail.com

Ahmed Ahmed Moniur Hegab, Doctor

CONTACT

+201158744246ahmed1111mostafa@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatric resident

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 17, 2025

Study Start

December 7, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-09