<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/NCT02202382</url>
  </required_header>
  <id_info>
    <org_study_id>KGR study</org_study_id>
    <nct_id>NCT02202382</nct_id>
  </id_info>
  <brief_title>Effects of Korean Red Ginseng on Male Infertility</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Hospital</source>
  <brief_summary>
    <textblock>
      Objective: Several in vitro studies report positive effects of ginseng on spermatogenesis.&#xD;
      However, no controlled human clinical study of the effect of Korean red ginseng (KRG) on&#xD;
      spermatogenesis has been performed. This study was performed to investigate the effects of&#xD;
      KRG on semen parameters in male infertility patients in a randomized, double-blind,&#xD;
      placebo-controlled study. Methods: A total of 80 male infertility patients with varicocele&#xD;
      were recruited from April 2011 to February 2012. The subjects were then divided into the&#xD;
      following four groups: non-V + P group, placebo; V + P group, placebo and varicocelectomy;&#xD;
      non-V + KRG group, 1.5-g KRG daily; V + KGR group, 1.5-g KRG daily and varicocelectomy. Semen&#xD;
      analysis was performed and hormonal levels were measured in each treatment arm after 12&#xD;
      weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sperm concentration</measure>
    <time_frame>When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period</time_frame>
    <description>Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sperm motility</measure>
    <time_frame>When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period</time_frame>
    <description>Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sperm morphology</measure>
    <time_frame>When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period</time_frame>
    <description>Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sperm viability</measure>
    <time_frame>When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period</time_frame>
    <description>Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations of FSH</measure>
    <time_frame>The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)</time_frame>
    <description>Serum hormonal levels were quantified by chemiluminescence assays</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations of LH</measure>
    <time_frame>The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)</time_frame>
    <description>Serum hormonal levels were quantified by chemiluminescence assays</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations of testosterone</measure>
    <time_frame>The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)</time_frame>
    <description>Serum hormonal levels were quantified by radioimmunoassay</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Male Infertility</condition>
  <arm_group>
    <arm_group_label>non-V + P group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>no surgery and placebo (12 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V + P group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgery with placebo (12 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-V + KRG group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V + KRG group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgery with KRG (1.5 gm daily 12weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Korean Red Ginseng, Varicocelectomy</intervention_name>
    <arm_group_label>V + KRG group</arm_group_label>
    <arm_group_label>non-V + KRG group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.</description>
    <arm_group_label>V + P group</arm_group_label>
    <arm_group_label>non-V + P group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Varicocelectomy</intervention_name>
    <description>Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.</description>
    <arm_group_label>V + KRG group</arm_group_label>
    <arm_group_label>V + P group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients should be males, 25 - 45 years of age&#xD;
&#xD;
          -  Complained of infertility for at least 12 months&#xD;
&#xD;
          -  No history of surgical or medical treatments for infertility&#xD;
&#xD;
          -  Increased retrograde flow in the internal spermatic vein with venous diameter &gt; 3 mm&#xD;
             during the Valsalva maneuver on scrotal ultrasonography was used as an indicator of&#xD;
             varicocele.13 Varicocele was graded according to the criteria presented by Lyon et&#xD;
             al.14: grade I, palpable only with the Valsalva maneuver; Grade II, palpable without&#xD;
             the Valsalva maneuver; Grade III, visible from a distance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria were as follows:&#xD;
&#xD;
          -  A history of vasectomy or obstructive azoospermia&#xD;
&#xD;
          -  Chromosomal abnormalities&#xD;
&#xD;
          -  Hypogonadism or pituitary abnormalities&#xD;
&#xD;
          -  Anatomical abnormality of the genitals&#xD;
&#xD;
          -  Significant hepatopathy (liver enzymes elevated 2 - 3-fold higher than the normal&#xD;
             range)&#xD;
&#xD;
          -  Renal insufficiency (serum creatinine level &gt; 2.5 mg/dL)&#xD;
&#xD;
          -  Medical treatment for infertility during the past 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Urology, Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Hospital</investigator_affiliation>
    <investigator_full_name>Hyun Jun Park</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT02202382
org study id: KGR study
nct id: NCT02202382
lead sponsor: 
Objective: Several in vitro studies report positive effects of ginseng on spermatogenesis.
      However, no controlled human clinical study of the effect of Korean red ginseng (KRG) on
      spermatogenesis has been performed. This study was performed to investigate the effects of
      KRG on semen parameters in male infertility patients in a randomized, double-blind,
      placebo-controlled study. Methods: A total of 80 male infertility patients with varicocele
      were recruited from April 2011 to February 2012. The subjects were then divided into the
      following four groups: non-V + P group, placebo; V + P group, placebo and varicocelectomy;
      non-V + KRG group, 1.5-g KRG daily; V + KGR group, 1.5-g KRG daily and varicocelectomy. Semen
      analysis was performed and hormonal levels were measured in each treatment arm after 12
      weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Sperm concentration
time frame: When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period
description: Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
measure: Sperm motility
time frame: When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period
description: Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
measure: Sperm morphology
time frame: When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period
description: Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
measure: Sperm viability
time frame: When 12 week treatments were finished in all treatment arms, semen analysis and determination of hormonal levels were performed after 2 weeks of washout period
description: Primary outcome measure according to World Health Organization (WHO) methodologies (4th edition)
measure: Serum concentrations of FSH
time frame: The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
description: Serum hormonal levels were quantified by chemiluminescence assays
measure: Serum concentrations of LH
time frame: The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
description: Serum hormonal levels were quantified by chemiluminescence assays
measure: Serum concentrations of testosterone
time frame: The hormonal status of all patients was recorded at the initial screening visit and post-treatment. (baseline and 12weeks after treatment)
description: Serum hormonal levels were quantified by radioimmunoassay
arm group label: non-V + P group
arm group type: Placebo Comparator
description: no surgery and placebo (12 weeks)
arm group label: V + P group
arm group type: Active Comparator
description: Surgery with placebo (12 weeks)
arm group label: non-V + KRG group
arm group type: Active Comparator
description: no surgery with KRG (korean red ginseng, 1.5 gm daily 12weeks)
arm group label: V + KRG group
arm group type: Experimental
description: Surgery with KRG (1.5 gm daily 12weeks)
intervention type: Drug
intervention name: Korean Red Ginseng, Varicocelectomy
arm group label: V + KRG group
arm group label: non-V + KRG group
intervention type: Drug
intervention name: Placebo
description: Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.
arm group label: V + P group
arm group label: non-V + P group
intervention type: Procedure
intervention name: Varicocelectomy
description: Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
arm group label: V + KRG group
arm group label: V + P group
criteria: 
gender: Male
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Hospital
investigator full name: Hyun Jun Park
investigator title: Professor
mesh term: Infertility
mesh term: Infertility, Male