<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/NCT03834831</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2018/8866</org_study_id>
    <nct_id>NCT03834831</nct_id>
  </id_info>
  <brief_title>Impact of Coenzyme Q10 and Selenium on Seminal Fluid and Semen Antioxidant Status</brief_title>
  <official_title>Impact of Coenzyme Q10 and Selenium on Seminal Fluid Parameters and Antioxidant Status in Men With Idiopathic Infertility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sumer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sumer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was conducted to assess the impact of coenzyme Q10 and selenium on seminal fluid&#xD;
      parameters and antioxidant status in infertile men.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to assess the impact of coenzyme Q10 and selenium on seminal fluid&#xD;
      parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Semen volume (WHO 2010 guidelines)</measure>
    <time_frame>3 months</time_frame>
    <description>Semen volume in ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sperm concentration in semen (WHO 2010 guidelines)</measure>
    <time_frame>3 months</time_frame>
    <description>Sperm concentration in million/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sperm motility in semen (WHO 2010 guidelines)</measure>
    <time_frame>3 months</time_frame>
    <description>Sperm motility (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sperm morphology in semen (WHO 2010 guidelines)</measure>
    <time_frame>3 months</time_frame>
    <description>Normal sperm morphology (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seminal plasma TAC (Colorimetric assays)</measure>
    <time_frame>3 months</time_frame>
    <description>Seminal plasma total antioxidant capacity in mmol/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seminal plasma CAT (Colorimetric assays)</measure>
    <time_frame>3 months</time_frame>
    <description>Seminal plasma catalase in U/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seminal plasma SOD (Colorimetric assays)</measure>
    <time_frame>3 months</time_frame>
    <description>Superoxide dismutase in U/ml</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Male Infertility</condition>
  <arm_group>
    <arm_group_label>Coenzyme Q10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Coenzyme Q10 200mg/day for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selenium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selenium mcg/day for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Coenzyme Q10</intervention_name>
    <description>Coenzyme Q10</description>
    <arm_group_label>Coenzyme Q10</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Selenium</intervention_name>
    <description>Selenium</description>
    <arm_group_label>Selenium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of infertility of at least 12 months despite regular unprotected intercourse.&#xD;
&#xD;
          -  Oligoasthenoteratospermia was diagnosed by semen analysis showing abnormal sperm&#xD;
             concentration (&lt;15 million/ml), progressive motility (&lt;32%), total motility (&lt;40%) and&#xD;
             morphology (&lt;30% WHO criteria) as defined by WHO manual for semen analysis 2010&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Azoospermia,&#xD;
&#xD;
          -  Varicocele,&#xD;
&#xD;
          -  Genital tract infection,&#xD;
&#xD;
          -  Cryptorchidism,&#xD;
&#xD;
          -  Testicular trauma or scrotal surgery,&#xD;
&#xD;
          -  Endocrine disorder,&#xD;
&#xD;
          -  Systemic illness,&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  The presence of female factor&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male infertility</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed T Alahmar</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sumer, Iraq</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fertility Unit, Babyl</name>
      <address>
        <city>Hilla</city>
        <zip>00964</zip>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <reference>
    <citation>Alshahrani S, Aldossari K, Al-Zahrani J, Gabr AH, Henkel R, Ahmad G. Interpretation of semen analysis using WHO 1999 and WHO 2010 reference values: Abnormal becoming normal. Andrologia. 2018 Mar;50(2). doi: 10.1111/and.12838. Epub 2017 Aug 3.</citation>
    <PMID>28771785</PMID>
  </reference>
  <reference>
    <citation>Alahmar AT. The effects of oral antioxidants on the semen of men with idiopathic oligoasthenoteratozoospermia. Clin Exp Reprod Med. 2018 Jun;45(2):57-66. doi: 10.5653/cerm.2018.45.2.57. Epub 2018 Jun 29.</citation>
    <PMID>29984205</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sumer</investigator_affiliation>
    <investigator_full_name>Dr. Ahmed T Alahmar</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Male infertility</keyword>
  <keyword>Coenzyme Q10</keyword>
  <keyword>Selenium</keyword>
  <keyword>Antioxidants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Selenium</mesh_term>
    <mesh_term>Ubiquinone</mesh_term>
    <mesh_term>Coenzyme Q10</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Patients data are anonymous and in hold with the principal investigator</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/NCT03834831
org study id: EC/2018/8866
nct id: NCT03834831
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study was conducted to assess the impact of coenzyme Q10 and selenium on seminal fluid
      parameters and antioxidant status in infertile men.
The aim of this study was to assess the impact of coenzyme Q10 and selenium on seminal fluid
      parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Semen volume (WHO 2010 guidelines)
time frame: 3 months
description: Semen volume in ml
measure: Sperm concentration in semen (WHO 2010 guidelines)
time frame: 3 months
description: Sperm concentration in million/ml
measure: Sperm motility in semen (WHO 2010 guidelines)
time frame: 3 months
description: Sperm motility (%)
measure: Sperm morphology in semen (WHO 2010 guidelines)
time frame: 3 months
description: Normal sperm morphology (%)
measure: Seminal plasma TAC (Colorimetric assays)
time frame: 3 months
description: Seminal plasma total antioxidant capacity in mmol/ml
measure: Seminal plasma CAT (Colorimetric assays)
time frame: 3 months
description: Seminal plasma catalase in U/ml
measure: Seminal plasma SOD (Colorimetric assays)
time frame: 3 months
description: Superoxide dismutase in U/ml
arm group label: Coenzyme Q10
arm group type: Active Comparator
description: Coenzyme Q10 200mg/day for 3 months
arm group label: Selenium
arm group type: Active Comparator
description: Selenium mcg/day for 3 months
intervention type: Dietary Supplement
intervention name: Coenzyme Q10
description: Coenzyme Q10
arm group label: Coenzyme Q10
intervention type: Dietary Supplement
intervention name: Selenium
description: Selenium
arm group label: Selenium
criteria: 
gender: Male
gender based: Yes
gender description: Male infertility
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed T Alahmar
role: Principal Investigator
affiliation: University of Sumer, Iraq
facility: 
country: Iraq
citation: Alshahrani S, Aldossari K, Al-Zahrani J, Gabr AH, Henkel R, Ahmad G. Interpretation of semen analysis using WHO 1999 and WHO 2010 reference values: Abnormal becoming normal. Andrologia. 2018 Mar;50(2). doi: 10.1111/and.12838. Epub 2017 Aug 3.
PMID: 28771785
citation: Alahmar AT. The effects of oral antioxidants on the semen of men with idiopathic oligoasthenoteratozoospermia. Clin Exp Reprod Med. 2018 Jun;45(2):57-66. doi: 10.5653/cerm.2018.45.2.57. Epub 2018 Jun 29.
PMID: 29984205
responsible party type: Principal Investigator
investigator affiliation: University of Sumer
investigator full name: Dr. Ahmed T Alahmar
investigator title: Principal Investigator
mesh term: Infertility
mesh term: Infertility, Male
mesh term: Selenium
mesh term: Ubiquinone
mesh term: Coenzyme Q10
sharing ipd: No
ipd description: Patients data are anonymous and in hold with the principal investigator