Thalassemia Majors (Beta-Thalassemia Major)NCT07288762
Gonadal Function in Thalassemic Patient
An observational study of Thalassemia Majors (Beta-Thalassemia Major), run by Sohag University.
Trial summary
Patient with transfusion depandant beta thalassemia with accumulation of iron in their body affect pituitary gland and gonades lead to impaired their functions . Read more about this study
- Who is it for?
- Ages 10 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Thalassemia Majors (Beta-Thalassemia Major)
- What is being tested?
- serum inhibin B serum INSL3 serum AMH
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: transfusion depandant beta thalassemia male patients age 10 - 18 year old age
Who may be able to join
- transfusion depandant beta thalassemia
- age 10 to 18 year old age
Who cannot join
- age below 10 year old age or above 18 year old age
- associated with another disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 .
Read the detailed description
detection of any abnormalities in pituitary gland hormones ( FSH , LH , serum prolactin ) gonadal hormones ( serum testesterone , antimullerian hormone , INSL3 , inhibin B hormone )
- Being tested
- serum inhibin B serum INSL3 serum AMH
- Keywords
- INSL3 or inhibin B hormone in transfusion depandant beta thalassemia
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum inhibin B serum INSL3 serum AMHDiagnostic test
transfusion depandant beta thalassemia with measure gonadal function serum INSL3 serum inhibin B serum AMH
| Study group | Role | What they receive |
|---|---|---|
| group 1 transfusion depandant beta thalassemia | transfusion depandant beta thalassemia 10 - 18 years old age gonadal function assesment Receives: Diagnostic Test: serum inhibin B serum INSL3 serum AMH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start7 Dec 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thalassemia Majors (Beta-Thalassemia Major)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Saadeldin Mohamed, Sohag University
- Investigators
- hager Saadeldin, resident, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288762
- Sponsor's protocol ID
- Soh-Med-25-9-18MS
- Status last verified
- Sep 2025
- First submitted
- 22 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gonadal Function in Boys With Transfusion Depandant Beta Thalassemia
- ClinicalTrials.gov ID
- NCT07288762
- Acronym / sponsor ID
- Soh-Med-25-9-18MS
- Keywords
- INSL3 or inhibin B hormone in transfusion depandant beta thalassemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 7 Dec 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient with transfusion depandant beta thalassemia with accumulation of iron in their body affect pituitary gland and gonades lead to impaired their functions .
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 transfusion depandant beta thalassemia | – | Diagnostic Test: serum inhibin B serum INSL3 serum AMHtransfusion depandant beta thalassemia 10 - 18 years old age gonadal function assesment |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- transfusion depandant beta thalassemia male patients age 10 - 18 year old age
Key inclusion criteria (2 listed)
- transfusion depandant beta thalassemia
- age 10 to 18 year old age
Key exclusion criteria (2 listed)
- age below 10 year old age or above 18 year old age
- associated with another disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum inhibin B serum INSL3 serum AMHtransfusion depandant beta thalassemia with measure gonadal function serum INSL3 serum inhibin B serum AMH | Diagnostic test | group 1 transfusion depandant beta thalassemia |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
hager Saadeldin, resident principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia Majors (Beta-Thalassemia Major), run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hager Saadeldin saadeldin, pediatric resident (+201065099621, hagersaadeldin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gonadal function in transfusion depandant beta thalassemia (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.