Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?

Phase 1

• Conditions: Endocrine Disease; Fertility Decreased Male; DNA Damage
• Interventions: Drug: L-Carnitine and N-acetyl cysteine

• Registration Number: NCT03014882
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Status Verified: 2017-01
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Last Update Submitted: 2017-01-06
• Study First Posted: 2017-01-09
• Last Update Posted: 2017-01-09
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Pubertal patients with beta thalassemia major

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Exclusion Criteria

• Associated endcrinopathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antioxidant treatment	L-Carnitine and N-acetyl cysteine	-

Primary Outcome Measures

Name	Time	Method
DNA fragmentation index	6 months

Trial Locations

Locations (2)

Ain Shams University; 🇪🇬 Cairo, Egypt

Ain Shams University Hospitals; 🇪🇬 Cairo Governorate, Cairo, Egypt