"Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04509869
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Varicocele; Pain; Fertility Issues	Procedure: varicocelectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Outcome of Subinguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
• Actual Study Start Date: Aug 12, 2017
• Actual Primary Completion Date: Aug 12, 2020
• Actual Study Completion Date: Aug 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pre-operative and postoperative the patients who will undergo the operation to treat the pain	Procedure: varicocelectomy; operation for varix ligation

Outcome Measures

Primary Outcome Measures

1. sperm motility [3 months postoperative is our aim]

   semen analysis will be done preoperative and post-operative

2. sperm morphology [3 months postoperative is our aim]

   semen analysis will be done preoperative and postoperative

3. sperm number [3 months postoperative is our aim]

   semen analysis will be done preoperative and postoperative

4. pain of scrotum [3 months postoperative is our aim]

   subjective sensation measured by visual analogue score preoperative and postoperative

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Primary varicocele

2. Patient's age more than 19 years

3. Normal semen analysis (according to the WHO 5th guide to semen parameters where sperm concentration equal 15 million per ml , total sperm number 40 million per ejaculate ,normal morphology 4 % and motility A =25% or a+b = 32% is considered normal.

4. Scrotal pain after exclusion of other causes.

Exclusion Criteria:

• 1- Recurrent varicocele

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Abd Ellatif ME, Asker W, Abbas A, Negm A, Al-Katary M, El-Kaffas H, Moatamed A. Varicocelectomy to treat pain, and predictors of success: a prospective study. Curr Urol. 2012 May;6(1):33-6. doi: 10.1159/000338867. Epub 2012 Mar 18.
• Chen SS. Factors predicting symptomatic relief by varicocelectomy in patients with normospermia and painful varicocele nonresponsive to conservative treatment. Urology. 2012 Sep;80(3):585-9. doi: 10.1016/j.urology.2012.05.014. Epub 2012 Jul 10.
• Cho CL, Esteves SC, Agarwal A. Indications and outcomes of varicocele repair. Panminerva Med. 2019 Jun;61(2):152-163. doi: 10.23736/S0031-0808.18.03528-0. Review.
• Maghraby HA. Laparoscopic varicocelectomy for painful varicoceles: merits and outcomes. J Endourol. 2002 Mar;16(2):107-10.
• Peterson AC, Lance RS, Ruiz HE. Outcomes of varicocele ligation done for pain. J Urol. 1998 May;159(5):1565-7.
• Yaman O, Ozdiler E, Anafarta K, Göğüş O. Effect of microsurgical subinguinal varicocele ligation to treat pain. Urology. 2000 Jan;55(1):107-8.

• Responsible Party: Abdelrahman Mohamed Abdelkader, chief resident of urology, Assiut University
• ClinicalTrials.gov Identifier: NCT04509869
• Other Study ID Numbers: orchialgia treatment
• First Posted: Aug 12, 2020
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Varicocele; Infertility

Study Results

No Results Posted as of Aug 14, 2020