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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03281915
Other study ID # varicocelectomy
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 25, 2017
Last updated September 11, 2017
Start date October 15, 2017
Est. completion date October 15, 2018

Study information

Verified date September 2017
Source Assiut University
Contact Abdelrahman M Abdelkader
Phone 01068336396
Email abdelrahmanmohamed.aa@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date October 15, 2018
Est. primary completion date October 15, 2018
Accepts healthy volunteers No
Gender Male
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria:

- age more than 19 years old

- primary varicocele

Exclusion Criteria:

- secondary varicocele recurrent varicocele age less than 19 years

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
High inguinal Varicocelectomy
Semen parameters after high inguinal varicocelectomy will be collected
Subinguinal varicocelectomy
Semen parameters after subinguinal Varicocelectomy will be collected

Locations

Country Name City State
Egypt Assuit Medical School Assiut Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

Leslie SW, Siref LE. Varicocele. 2017 Aug 24. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2017 Jun-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448113/ — View Citation

Schmidt B. Membranes in artificial organs. Artif Organs. 1996 May;20(5):375-80. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Semen analysis Motility morphology concentration 3months
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