<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014882</url>
  </required_header>
  <id_info>
    <org_study_id>Endocrinology PECASU</org_study_id>
    <nct_id>NCT03014882</nct_id>
  </id_info>
  <brief_title>Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?</brief_title>
  <official_title>Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Accumulation of iron in patients with beta thalassemia major causes free radical formation&#xD;
      which leads to damage of biological membranes. Sperm DNA damage may result from these&#xD;
      generated antioxidants.&#xD;
&#xD;
      We aimed at investigating the current DNA damage in the sperms of adult patients with beta&#xD;
      thalassemia major and the effect generated by giving antioxidant treatment for 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DNA fragmentation index</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Endocrine Disease</condition>
  <condition>Fertility Decreased Male</condition>
  <condition>DNA Damage</condition>
  <arm_group>
    <arm_group_label>Antioxidant treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L-Carnitine and N-acetyl cysteine</intervention_name>
    <arm_group_label>Antioxidant treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pubertal patients with beta thalassemia major&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated endcrinopathy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heba H Elsedfy, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University Hospitals</name>
      <address>
        <city>Cairo Governorate</city>
        <state>Cairo</state>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo Governorate</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Alaa Youssef Ahmed</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalassemia</mesh_term>
    <mesh_term>beta-Thalassemia</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014882
org study id: Endocrinology PECASU
nct id: NCT03014882
lead sponsor: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: DNA fragmentation index
time frame: 6 months
arm group label: Antioxidant treatment
arm group type: Other
intervention type: Drug
intervention name: L-Carnitine and N-acetyl cysteine
arm group label: Antioxidant treatment
criteria: 
gender: Male
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Heba H Elsedfy, Professor
role: Principal Investigator
affiliation: Ain Shams University
facility: 
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Alaa Youssef Ahmed
investigator title: Dr
mesh term: Thalassemia
mesh term: beta-Thalassemia
mesh term: Endocrine System Diseases
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine
sharing ipd: Undecided