Gonadal Function in Thalassemic Patient

December 4, 2025 updated by: Hager Saadeldin Mohamed, Sohag University

Gonadal Function in Boys With Transfusion Depandant Beta Thalassemia

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

detection of any abnormalities in pituitary gland hormones ( FSH , LH , serum prolactin ) gonadal hormones ( serum testesterone , antimullerian hormone , INSL3 , inhibin B hormone )

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
transfusion depandant beta thalassemia with measure gonadal function serum INSL3 serum inhibin B serum AMH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gonadal function in transfusion depandant beta thalassemia
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: hager Saadeldin, resident, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 7, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-25-9-18MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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