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the Effect of Different Modialites of Varicocelectomy on Semen Parameters in Patient With Normal Semen Analysis

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ClinicalTrials.gov Identifier: NCT03281915
Recruitment Status : Unknown
Verified September 2017 by Abdelrahman Mohamed Abdelkader, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Mohamed Abdelkader, Assiut University

Brief Summary:
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)

Condition or disease Intervention/treatment
Varicocele Procedure: High inguinal Varicocelectomy Procedure: Subinguinal varicocelectomy

Detailed Description:

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

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison Between Impact of Inguinal and Subinguinal Approaches of Varicocelectomy on Semen Parameters in Patients With Normal Semen Analysis
Estimated Study Start Date : October 15, 2017
Estimated Primary Completion Date : October 15, 2018
Estimated Study Completion Date : October 15, 2018

Group/Cohort Intervention/treatment
high inguinal approch
Patients undergoing high inguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded
Procedure: High inguinal Varicocelectomy
Semen parameters after high inguinal varicocelectomy will be collected

subinguinal approch
Patients undergoing subinguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded
Procedure: Subinguinal varicocelectomy
Semen parameters after subinguinal Varicocelectomy will be collected




Primary Outcome Measures :
  1. Semen analysis [ Time Frame: 3months ]
    Motility morphology concentration



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients undergoing varicocelectomy while having normal semen parameters (doing surgery for other reasons eg. pain)
Criteria

Inclusion Criteria:

  • age more than 19 years old
  • primary varicocele

Exclusion Criteria:

  • secondary varicocele recurrent varicocele age less than 19 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281915


Contacts
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Contact: Abdelrahman M Abdelkader 01068336396 abdelrahmanmohamed.aa@gmail.com
Contact: Mohamed A Osman, professor 01062226639 ext 0882315760 osman@aun.edu.eg

Locations
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Egypt
Assuit Medical School
Assiut, Assuit, Egypt, 71621
Contact: Abdelrahman M Abdelkader, resident    01068336396    abdelrahmanmohamed.aa@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Ehab O Ahmed unaffiliation
Study Chair: Mohamed I Taha unaffiliation
Study Director: Ahmed k mohamed unaffiliation
Publications:
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Responsible Party: Abdelrahman Mohamed Abdelkader, Resident, Assiut University
ClinicalTrials.gov Identifier: NCT03281915    
Other Study ID Numbers: varicocelectomy
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdelrahman Mohamed Abdelkader, Assiut University:
infertility
pain
pregnancy
Additional relevant MeSH terms:
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Varicocele
Genital Diseases, Male
Vascular Diseases
Cardiovascular Diseases