<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/NCT03281915</url>
  </required_header>
  <id_info>
    <org_study_id>varicocelectomy</org_study_id>
    <nct_id>NCT03281915</nct_id>
  </id_info>
  <brief_title>the Effect of Different Modialites of Varicocelectomy on Semen Parameters in Patient With Normal Semen Analysis</brief_title>
  <official_title>Comparison Between Impact of Inguinal and Subinguinal Approaches of Varicocelectomy on Semen Parameters in Patients 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>Yes</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>
      to evalute the effect inguinal and subinguinal approach of varicoceclectomy on semen&#xD;
      parameter for patients complaining of varicocele with normal semen parameter (pain is the&#xD;
      main complaint)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the varicocele is defined as dilated and incompetent veins within the pampiniform plexus of&#xD;
      spermatic cord. varicocele has been described as the most common surgically correctable cause&#xD;
      of male subinfertility.this is a disease that devolops during puberty when both endocrine and&#xD;
      exocrine function of the testicle dramatically increases, along with testicular blood flow.&#xD;
      varicocele only rarely detected in boys less than 10 years. left sided varicocle found in 15%&#xD;
      of healthy young men.incontrast, the incidence in sub fertile men approaches 40% bilateral&#xD;
      varicocele is uncommon in healthy men (less than 10%) but palpated in 20% in sub fertile men.&#xD;
      in-general varicocele don't spontaneously regress. an accurate physical examination remain&#xD;
      the corner stone of varicocele diagnosis.&#xD;
&#xD;
      several anatomic features contribute to the predominance of left sided varicocele is the left&#xD;
      intrnal spermatic vein longer than the right and it typically joins the left renal vein at a&#xD;
      right angle.as result of this character higher venous pressures fair transmited to the left&#xD;
      spermatic vein and result in reterograde reflux of blood.&#xD;
&#xD;
      varicocle are associated with testicular atrophhy and varicocle correction can reverse&#xD;
      atrophy in adolececnt. there is strong evidence affect semen quality it can cause&#xD;
      abnormalties in concentration, motility and morphology.main defect is the motility.&#xD;
&#xD;
      indication of varicocelectomy:&#xD;
&#xD;
        1. Large varicoceles in adolescents&#xD;
&#xD;
        2. Childhood varicocele with testicular atrophy&#xD;
&#xD;
        3. Varicoceles with elevated FSH values, or low testosterone levels&#xD;
&#xD;
        4. Varicoceles with scrotal pain&#xD;
&#xD;
        5. Cosmetic indication&#xD;
&#xD;
        6. Male infertility with pathological semen analysis and varicocele&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 15, 2017</start_date>
  <completion_date type="Anticipated">October 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2018</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>Semen analysis</measure>
    <time_frame>3months</time_frame>
    <description>Motility morphology concentration</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Varicocele</condition>
  <arm_group>
    <arm_group_label>high inguinal approch</arm_group_label>
    <description>Patients undergoing high inguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded</description>
  </arm_group>
  <arm_group>
    <arm_group_label>subinguinal approch</arm_group_label>
    <description>Patients undergoing subinguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High inguinal Varicocelectomy</intervention_name>
    <description>Semen parameters after high inguinal varicocelectomy will be collected</description>
    <arm_group_label>high inguinal approch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subinguinal varicocelectomy</intervention_name>
    <description>Semen parameters after subinguinal Varicocelectomy will be collected</description>
    <arm_group_label>subinguinal approch</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male patients undergoing varicocelectomy while having normal semen parameters (doing&#xD;
        surgery for other reasons eg. pain)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age more than 19 years old&#xD;
&#xD;
          -  primary varicocele&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary varicocele recurrent varicocele age less than 19 years&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ehab O Ahmed</last_name>
    <role>Study Director</role>
    <affiliation>unaffiliation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed I Taha</last_name>
    <role>Study Chair</role>
    <affiliation>unaffiliation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed k mohamed</last_name>
    <role>Study Director</role>
    <affiliation>unaffiliation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abdelrahman M Abdelkader</last_name>
    <phone>01068336396</phone>
    <email>abdelrahmanmohamed.aa@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed A Osman, professor</last_name>
    <phone>01062226639</phone>
    <phone_ext>0882315760</phone_ext>
    <email>osman@aun.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assuit Medical School</name>
      <address>
        <city>Assiut</city>
        <state>Assuit</state>
        <zip>71621</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Abdelrahman M Abdelkader, resident</last_name>
      <phone>01068336396</phone>
      <email>abdelrahmanmohamed.aa@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Leslie SW, Sajjad H, Siref LE. Varicocele. 2023 May 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448113/</citation>
    <PMID>28846314</PMID>
  </reference>
  <reference>
    <citation>Wu X, Liu Q, Zhang R, Wang W, Gao Y. Therapeutic efficacy and safety of laparoscopic surgery versus microsurgery for varicocele of adult males: A meta-analysis. Medicine (Baltimore). 2017 Aug;96(34):e7818. doi: 10.1097/MD.0000000000007818.</citation>
    <PMID>28834886</PMID>
  </reference>
  <reference>
    <citation>Canning DA. Re: Sperm Concentration and Forward Motility are Not Correlated with Age in Adolescents with an Idiopathic Varicocele and Symmetrical Testicular Volumes. J Urol. 2017 Sep;198(3):472. doi: 10.1016/j.juro.2017.06.068. Epub 2017 Jun 20. No abstract available.</citation>
    <PMID>28817895</PMID>
  </reference>
  <reference>
    <citation>Schmidt B. Membranes in artificial organs. Artif Organs. 1996 May;20(5):375-80. doi: 10.1111/j.1525-1594.1996.tb04519.x.</citation>
    <PMID>8725614</PMID>
  </reference>
  <reference>
    <citation>Sedaghatpour D, Berookhim BM. The Role of Varicocele in Male Factor Subfertility. Curr Urol Rep. 2017 Sep;18(9):73. doi: 10.1007/s11934-017-0713-8.</citation>
    <PMID>28718159</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</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</investigator_title>
  </responsible_party>
  <keyword>infertility</keyword>
  <keyword>pain</keyword>
  <keyword>pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicocele</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/NCT03281915
org study id: varicocelectomy
nct id: NCT03281915
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
to evalute the effect inguinal and subinguinal approach of varicoceclectomy on semen
      parameter for patients complaining of varicocele with normal semen parameter (pain is the
      main complaint)
the varicocele is defined as dilated and incompetent veins within the pampiniform plexus of
      spermatic cord. varicocele has been described as the most common surgically correctable cause
      of male subinfertility.this is a disease that devolops during puberty when both endocrine and
      exocrine function of the testicle dramatically increases, along with testicular blood flow.
      varicocele only rarely detected in boys less than 10 years. left sided varicocle found in 15%
      of healthy young men.incontrast, the incidence in sub fertile men approaches 40% bilateral
      varicocele is uncommon in healthy men (less than 10%) but palpated in 20% in sub fertile men.
      in-general varicocele don't spontaneously regress. an accurate physical examination remain
      the corner stone of varicocele diagnosis.

      several anatomic features contribute to the predominance of left sided varicocele is the left
      intrnal spermatic vein longer than the right and it typically joins the left renal vein at a
      right angle.as result of this character higher venous pressures fair transmited to the left
      spermatic vein and result in reterograde reflux of blood.

      varicocle are associated with testicular atrophhy and varicocle correction can reverse
      atrophy in adolececnt. there is strong evidence affect semen quality it can cause
      abnormalties in concentration, motility and morphology.main defect is the motility.

      indication of varicocelectomy:

        1. Large varicoceles in adolescents

        2. Childhood varicocele with testicular atrophy

        3. Varicoceles with elevated FSH values, or low testosterone levels

        4. Varicoceles with scrotal pain

        5. Cosmetic indication

        6. Male infertility with pathological semen analysis and varicocele
observational model: Case-Only
time perspective: Prospective
measure: Semen analysis
time frame: 3months
description: Motility morphology concentration
arm group label: high inguinal approch
description: Patients undergoing high inguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded
arm group label: subinguinal approch
description: Patients undergoing subinguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded
intervention type: Procedure
intervention name: High inguinal Varicocelectomy
description: Semen parameters after high inguinal varicocelectomy will be collected
arm group label: high inguinal approch
intervention type: Procedure
intervention name: Subinguinal varicocelectomy
description: Semen parameters after subinguinal Varicocelectomy will be collected
arm group label: subinguinal approch
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ehab O Ahmed
role: Study Director
affiliation: unaffiliation
last name: Mohamed I Taha
role: Study Chair
affiliation: unaffiliation
last name: Ahmed k mohamed
role: Study Director
affiliation: unaffiliation
last name: Abdelrahman M Abdelkader
phone: 01068336396
email: abdelrahmanmohamed.aa@gmail.com
last name: Mohamed A Osman, professor
phone: 01062226639
phone ext: 0882315760
email: osman@aun.edu.eg
facility: 
contact: 
country: Egypt
citation: Leslie SW, Sajjad H, Siref LE. Varicocele. 2023 May 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448113/
PMID: 28846314
citation: Wu X, Liu Q, Zhang R, Wang W, Gao Y. Therapeutic efficacy and safety of laparoscopic surgery versus microsurgery for varicocele of adult males: A meta-analysis. Medicine (Baltimore). 2017 Aug;96(34):e7818. doi: 10.1097/MD.0000000000007818.
PMID: 28834886
citation: Canning DA. Re: Sperm Concentration and Forward Motility are Not Correlated with Age in Adolescents with an Idiopathic Varicocele and Symmetrical Testicular Volumes. J Urol. 2017 Sep;198(3):472. doi: 10.1016/j.juro.2017.06.068. Epub 2017 Jun 20. No abstract available.
PMID: 28817895
citation: Schmidt B. Membranes in artificial organs. Artif Organs. 1996 May;20(5):375-80. doi: 10.1111/j.1525-1594.1996.tb04519.x.
PMID: 8725614
citation: Sedaghatpour D, Berookhim BM. The Role of Varicocele in Male Factor Subfertility. Curr Urol Rep. 2017 Sep;18(9):73. doi: 10.1007/s11934-017-0713-8.
PMID: 28718159
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Abdelrahman Mohamed Abdelkader
investigator title: Resident
mesh term: Varicocele