Back to results"Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
Primary Purpose
Varicocele, Pain, Fertility Issues
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
varicocelectomy
Sponsored by
About this trial
This is an interventional treatment trial for Varicocele
Eligibility Criteria
Inclusion Criteria:
- Primary varicocele
- Patient's age more than 19 years
- 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.
- Scrotal pain after exclusion of other causes.
Exclusion Criteria:
- 1- Recurrent varicocele
Sites / Locations
- Assuit Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pre-operative and postoperative
Arm Description
the patients who will undergo the operation to treat the pain
Outcomes
Primary Outcome Measures
sperm motility
semen analysis will be done preoperative and post-operative
sperm morphology
semen analysis will be done preoperative and postoperative
sperm number
semen analysis will be done preoperative and postoperative
pain of scrotum
subjective sensation measured by visual analogue score preoperative and postoperative
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04509869
Brief Title
"Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
Official Title
Outcome of Subinguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 12, 2017 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
August 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele, Pain, Fertility Issues
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pre-operative and postoperative
Arm Type
Experimental
Arm Description
the patients who will undergo the operation to treat the pain
Intervention Type
Procedure
Intervention Name(s)
varicocelectomy
Intervention Description
operation for varix ligation
Primary Outcome Measure Information:
Title
sperm motility
Description
semen analysis will be done preoperative and post-operative
Time Frame
3 months postoperative is our aim
Title
sperm morphology
Description
semen analysis will be done preoperative and postoperative
Time Frame
3 months postoperative is our aim
Title
sperm number
Description
semen analysis will be done preoperative and postoperative
Time Frame
3 months postoperative is our aim
Title
pain of scrotum
Description
subjective sensation measured by visual analogue score preoperative and postoperative
Time Frame
3 months postoperative is our aim
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary varicocele
Patient's age more than 19 years
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.
Scrotal pain after exclusion of other causes.
Exclusion Criteria:
1- Recurrent varicocele
Facility Information:
Facility Name
Assuit Medical School
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71621
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22784493
Citation
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.
Results Reference
background
PubMed Identifier
24917707
Citation
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.
Results Reference
background
PubMed Identifier
30990285
Citation
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.
Results Reference
background
PubMed Identifier
11962551
Citation
Maghraby HA. Laparoscopic varicocelectomy for painful varicoceles: merits and outcomes. J Endourol. 2002 Mar;16(2):107-10. doi: 10.1089/089277902753619627.
Results Reference
background
PubMed Identifier
9554356
Citation
Peterson AC, Lance RS, Ruiz HE. Outcomes of varicocele ligation done for pain. J Urol. 1998 May;159(5):1565-7. doi: 10.1097/00005392-199805000-00043.
Results Reference
background
PubMed Identifier
10654904
Citation
Yaman O, Ozdiler E, Anafarta K, Gogus O. Effect of microsurgical subinguinal varicocele ligation to treat pain. Urology. 2000 Jan;55(1):107-8. doi: 10.1016/s0090-4295(99)00374-x.
Results Reference
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"Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
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