Clincosm LogoSign in Get a demo

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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03281915
Collaborator
(none)
32
Enrollment
1
Location
12
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Study Start Date :
Oct 15, 2017
Anticipated Primary Completion Date :
Oct 15, 2018
Anticipated Study Completion Date :
Oct 15, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Semen analysis [3months]

    Motility morphology concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • age more than 19 years old

  • primary varicocele

Exclusion Criteria:
  • secondary varicocele recurrent varicocele age less than 19 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assuit Medical School Assiut Assuit Egypt 71621

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Ehab O Ahmed, unaffiliation
  • Study Chair: Mohamed I Taha, unaffiliation
  • Study Director: Ahmed k mohamed, unaffiliation

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdelrahman Mohamed Abdelkader, Resident, Assiut University
ClinicalTrials.gov Identifier:
NCT03281915
Other Study ID Numbers:
  • varicocelectomy
First Posted:
Sep 13, 2017
Last Update Posted:
Sep 13, 2017
Last Verified:
Sep 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abdelrahman Mohamed Abdelkader, Resident, Assiut University
infertility
pain
pregnancy
Additional relevant MeSH terms:
Varicocele

Study Results

No Results Posted as of Sep 13, 2017