<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/NCT02217189</url>
  </required_header>
  <id_info>
    <org_study_id>Babil-3</org_study_id>
    <nct_id>NCT02217189</nct_id>
  </id_info>
  <brief_title>Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers</brief_title>
  <official_title>Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers in Spermatozoa of Patients With Asthenospermia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Babylon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Iraq</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Babylon University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although several studies have considered the relationship between infertility and semen super&#xD;
      oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as&#xD;
      oral zinc supplementation on superoxide radical scavengers activity which are important in&#xD;
      fertility of the individual has been reported.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study was conducted to study the effect of zinc supplementation on the&#xD;
      quantitative and qualitative characteristics of semen along with superoxide radical&#xD;
      scavengers activity in the seminal plasma of asthenospermic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxido-sensitive index level in spermatozoa and seminal plasma.</measure>
    <time_frame>up to three months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Volume of semen.</measure>
    <time_frame>up to three months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Xanthine oxidase activity in spermatozoa and seminal plasma.</measure>
    <time_frame>up to three months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catalase like activity in spermatozoa and seminal plasma.</measure>
    <time_frame>up to three months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superoxide dismutase activity in spermatozoa and seminal plasma.</measure>
    <time_frame>up to three months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progressive sperm motility percentage.</measure>
    <time_frame>up to three months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total normal sperm count.</measure>
    <time_frame>up to three months.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Asthenozoospermia</condition>
  <arm_group>
    <arm_group_label>Zinc sulfate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>60 fertile (age 31.6±3.3 year) men, no treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>zinc sulfate</intervention_name>
    <description>The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).</description>
    <arm_group_label>Zinc sulfate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the presence of asthenozoospermia in the semen sample.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the absence of endocrinopathy, varicocele, and female factor infertility. Smokers and&#xD;
             alcoholic men were excluded from the study because of their recognized high seminal&#xD;
             ROS levels and decreased antioxidant levels.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud H. Hadwan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Babylon University/ Iraq</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lamia A. Almashhedy, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Babylon University/ Iraq</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abdulrrazaq S. Alsalman, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Babylon University/ Iraq</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Babylon University</name>
      <address>
        <city>Hilla</city>
        <state>Babylon</state>
        <zip>51002</zip>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Babylon University</investigator_affiliation>
    <investigator_full_name>mahmoud hussein hadwan</investigator_full_name>
    <investigator_title>Mahmoud Hussein Hadwan</investigator_title>
  </responsible_party>
  <keyword>Zinc supplementation.</keyword>
  <keyword>Oxidative stress.</keyword>
  <keyword>Superoxide radical scavengers.</keyword>
  <keyword>Asthenospermia.</keyword>
  <keyword>Oxido-sensitive index.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthenozoospermia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zinc Sulfate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02217189
org study id: Babil-3
nct id: NCT02217189
lead sponsor: 
collaborator: 
has dmc: No
Although several studies have considered the relationship between infertility and semen super
      oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as
      oral zinc supplementation on superoxide radical scavengers activity which are important in
      fertility of the individual has been reported.
The present study was conducted to study the effect of zinc supplementation on the
      quantitative and qualitative characteristics of semen along with superoxide radical
      scavengers activity in the seminal plasma of asthenospermic patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oxido-sensitive index level in spermatozoa and seminal plasma.
time frame: up to three months.
measure: Volume of semen.
time frame: up to three months.
measure: Xanthine oxidase activity in spermatozoa and seminal plasma.
time frame: up to three months.
measure: Catalase like activity in spermatozoa and seminal plasma.
time frame: up to three months.
measure: Superoxide dismutase activity in spermatozoa and seminal plasma.
time frame: up to three months.
measure: Progressive sperm motility percentage.
time frame: up to three months
measure: Total normal sperm count.
time frame: up to three months.
arm group label: Zinc sulfate
arm group type: Experimental
description: 60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
arm group label: Healthy control
arm group type: No Intervention
description: 60 fertile (age 31.6±3.3 year) men, no treatment.
intervention type: Dietary Supplement
intervention name: zinc sulfate
description: The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
arm group label: Zinc sulfate
criteria: 
gender: Male
minimum age: 26 Years
maximum age: 36 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud H. Hadwan, PhD
role: Principal Investigator
affiliation: Babylon University/ Iraq
last name: Lamia A. Almashhedy, PhD
role: Study Director
affiliation: Babylon University/ Iraq
last name: Abdulrrazaq S. Alsalman, PhD
role: Study Chair
affiliation: Babylon University/ Iraq
facility: 
country: Iraq
responsible party type: Principal Investigator
investigator affiliation: Babylon University
investigator full name: mahmoud hussein hadwan
investigator title: Mahmoud Hussein Hadwan
mesh term: Asthenozoospermia
mesh term: Zinc Sulfate