<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/NCT02985905</url>
  </required_header>
  <id_info>
    <org_study_id>Babil-4</org_study_id>
    <nct_id>NCT02985905</nct_id>
  </id_info>
  <brief_title>The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index</brief_title>
  <official_title>The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index and Thiol Related Enzymes in Spermatozoa of Iraqi Asthenospermic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>mahmoud hussein hadwan</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 thiol&#xD;
      compounds levels, no study on the effects of asthenospermia treatments such as oral zinc&#xD;
      supplementation on thiol related enzymes activity which are important in fertility of the&#xD;
      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 reduced thiol, oxidized&#xD;
      thiol and thiol related enzymes 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">July 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>Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels.</measure>
    <time_frame>up to three months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glutathione peroxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Glutathione peroxidase activity levels.</measure>
    <time_frame>up to three months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sulfhydryl oxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Sulfhydryl oxidase activity levels.</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 Hadwan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Babylon University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>L Almashhedy, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Babylon University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alsalman Abdulrrazaq, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Babylon University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mahmoud Hadwan</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>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Babylon University</investigator_affiliation>
    <investigator_full_name>mahmoud hussein hadwan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Zinc supplementation</keyword>
  <keyword>Thiol</keyword>
  <keyword>Glutathione peroxidase</keyword>
  <keyword>Sulfhydryl oxidase</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>I plan to publish the results in a scientific journal</ipd_description>
  </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/NCT02985905
org study id: Babil-4
nct id: NCT02985905
lead sponsor: 
collaborator: 
has dmc: No
Although several studies have considered the relationship between infertility and semen thiol
      compounds levels, no study on the effects of asthenospermia treatments such as oral zinc
      supplementation on thiol related enzymes 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 reduced thiol, oxidized
      thiol and thiol related enzymes in the seminal plasma of asthenospermic patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels.
time frame: up to three months.
measure: Glutathione peroxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Glutathione peroxidase activity levels.
time frame: up to three months.
measure: Sulfhydryl oxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Sulfhydryl oxidase activity levels.
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 Hadwan, PhD
role: Principal Investigator
affiliation: Babylon University
last name: L Almashhedy, PhD
role: Study Director
affiliation: Babylon University
last name: Alsalman Abdulrrazaq, PhD
role: Study Chair
affiliation: Babylon University
facility: 
country: Iraq
responsible party type: Sponsor-Investigator
investigator affiliation: Babylon University
investigator full name: mahmoud hussein hadwan
investigator title: Principal Investigator
mesh term: Asthenozoospermia
mesh term: Zinc Sulfate
sharing ipd: Yes
ipd description: I plan to publish the results in a scientific journal