Back to resultsSperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?
Primary Purpose
Endocrine Disease, Fertility Decreased Male, DNA Damage
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
L-Carnitine and N-acetyl cysteine
Sponsored by
About this trial
This is an interventional treatment trial for Endocrine Disease
Eligibility Criteria
Inclusion Criteria:
- Pubertal patients with beta thalassemia major
Exclusion Criteria:
- Associated endcrinopathy
Sites / Locations
- Ain Shams University Hospitals
- Ain Shams University
- Ain Shams University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Antioxidant treatment
Arm Description
Outcomes
Primary Outcome Measures
DNA fragmentation index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03014882
Brief Title
Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?
Official Title
Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Accumulation of iron in patients with beta thalassemia major causes free radical formation which leads to damage of biological membranes. Sperm DNA damage may result from these generated antioxidants.
We aimed at investigating the current DNA damage in the sperms of adult patients with beta thalassemia major and the effect generated by giving antioxidant treatment for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine Disease, Fertility Decreased Male, DNA Damage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antioxidant treatment
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
L-Carnitine and N-acetyl cysteine
Primary Outcome Measure Information:
Title
DNA fragmentation index
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pubertal patients with beta thalassemia major
Exclusion Criteria:
Associated endcrinopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba H Elsedfy, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo Governorate
State/Province
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Name
Ain Shams University
City
Cairo Governorate
Country
Egypt
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?
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