<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/NCT03835143</url>
  </required_header>
  <id_info>
    <org_study_id>varicocle pain</org_study_id>
    <nct_id>NCT03835143</nct_id>
  </id_info>
  <brief_title>Outcome of Sub-inguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchilagia With Normal Semen</brief_title>
  <official_title>the Effect of Sub-inguinal Varicocelectomy in Patients Complaining of Orchialgia With Normal Semen Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of&#xD;
      varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes&#xD;
      and others do not.&#xD;
&#xD;
      Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those&#xD;
      studies dont report on postoperative semen.&#xD;
&#xD;
      This study will focus on the effect of operation on the semen postoperatively .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2019</start_date>
  <completion_date type="Actual">January 12, 2020</completion_date>
  <primary_completion_date type="Actual">September 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Grades of Motility of sperm in semen analysis</measure>
    <time_frame>3 months after the operation</time_frame>
    <description>semen analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Count of sperms in semen analysis</measure>
    <time_frame>3 months after the operation</time_frame>
    <description>semen analysis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain improvement using Numeric Pain Rating Scale</measure>
    <time_frame>3 months after the operation</time_frame>
    <description>semen analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>duppler</measure>
    <time_frame>3 months after the operation</time_frame>
    <description>doppler will be done to evaluate the veins pre and postoperative</description>
  </other_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Varices; Cord</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>subinguinal varicocelectomy</intervention_name>
    <description>varicocele ligation done at the level of subinguinal region</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        there is no description&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary varicocele.&#xD;
&#xD;
          2. Patient's age more than 20 years.&#xD;
&#xD;
          3. Scrotal pain (after exclusion of other causes).&#xD;
&#xD;
          4. Normal semen analysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Secondary varicocele.&#xD;
&#xD;
          2. Recurrent varicocele.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assuit Medical School</name>
      <address>
        <city>Assiut</city>
        <state>Assuit</state>
        <zip>71621</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Cayan S, Shavakhabov S, Kadioglu A. Treatment of palpable varicocele in infertile men: a meta-analysis to define the best technique. J Androl. 2009 Jan-Feb;30(1):33-40. doi: 10.2164/jandrol.108.005967. Epub 2008 Sep 4.</citation>
    <PMID>18772487</PMID>
  </results_reference>
  <results_reference>
    <citation>Kupis L, Dobronski PA, Radziszewski P. Varicocele as a source of male infertility - current treatment techniques. Cent European J Urol. 2015;68(3):365-70. doi: 10.5173/ceju.2015.642. Epub 2015 Oct 15.</citation>
    <PMID>26568883</PMID>
  </results_reference>
  <results_reference>
    <citation>Shabana W, Teleb M, Dawod T, Elsayed E, Desoky E, Shahin A, Eladl M, Sorour W. Predictors of improvement in semen parameters after varicocelectomy for male subfertility: A prospective study. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):E579-82. doi: 10.5489/cuaj.2808. Epub 2015 Sep 9.</citation>
    <PMID>26425217</PMID>
  </results_reference>
  <results_reference>
    <citation>Paick S, Choi WS. Varicocele and Testicular Pain: A Review. World J Mens Health. 2019 Jan;37(1):4-11. doi: 10.5534/wjmh.170010. Epub 2018 May 16.</citation>
    <PMID>29774668</PMID>
  </results_reference>
  <results_reference>
    <citation>Cho CL, Esteves SC, Agarwal A. Novel insights into the pathophysiology of varicocele and its association with reactive oxygen species and sperm DNA fragmentation. Asian J Androl. 2016 Mar-Apr;18(2):186-93. doi: 10.4103/1008-682X.170441.</citation>
    <PMID>26732105</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 4, 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>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Abdelrahman Mohamed Abdelkader</investigator_full_name>
    <investigator_title>resident of urology</investigator_title>
  </responsible_party>
  <!-- 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/NCT03835143
org study id: varicocle pain
nct id: NCT03835143
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of
      varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes
      and others do not.

      Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those
      studies dont report on postoperative semen.

      This study will focus on the effect of operation on the semen postoperatively .
observational model: Case-Only
time perspective: Prospective
measure: Grades of Motility of sperm in semen analysis
time frame: 3 months after the operation
description: semen analysis
measure: Count of sperms in semen analysis
time frame: 3 months after the operation
description: semen analysis
measure: Pain improvement using Numeric Pain Rating Scale
time frame: 3 months after the operation
description: semen analysis
measure: duppler
time frame: 3 months after the operation
description: doppler will be done to evaluate the veins pre and postoperative
intervention type: Procedure
intervention name: subinguinal varicocelectomy
description: varicocele ligation done at the level of subinguinal region
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
citation: Cayan S, Shavakhabov S, Kadioglu A. Treatment of palpable varicocele in infertile men: a meta-analysis to define the best technique. J Androl. 2009 Jan-Feb;30(1):33-40. doi: 10.2164/jandrol.108.005967. Epub 2008 Sep 4.
PMID: 18772487
citation: Kupis L, Dobronski PA, Radziszewski P. Varicocele as a source of male infertility - current treatment techniques. Cent European J Urol. 2015;68(3):365-70. doi: 10.5173/ceju.2015.642. Epub 2015 Oct 15.
PMID: 26568883
citation: Shabana W, Teleb M, Dawod T, Elsayed E, Desoky E, Shahin A, Eladl M, Sorour W. Predictors of improvement in semen parameters after varicocelectomy for male subfertility: A prospective study. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):E579-82. doi: 10.5489/cuaj.2808. Epub 2015 Sep 9.
PMID: 26425217
citation: Paick S, Choi WS. Varicocele and Testicular Pain: A Review. World J Mens Health. 2019 Jan;37(1):4-11. doi: 10.5534/wjmh.170010. Epub 2018 May 16.
PMID: 29774668
citation: Cho CL, Esteves SC, Agarwal A. Novel insights into the pathophysiology of varicocele and its association with reactive oxygen species and sperm DNA fragmentation. Asian J Androl. 2016 Mar-Apr;18(2):186-93. doi: 10.4103/1008-682X.170441.
PMID: 26732105
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Abdelrahman Mohamed Abdelkader
investigator title: resident of urology