NCT04509869

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

August 7, 2020

Last Update Submit

August 13, 2020

Conditions

VaricocelePainFertility Issues

Outcome Measures

Primary Outcomes (4)

  • sperm motility

    semen analysis will be done preoperative and post-operative

    3 months postoperative is our aim

  • sperm morphology

    semen analysis will be done preoperative and postoperative

    3 months postoperative is our aim

  • sperm number

    semen analysis will be done preoperative and postoperative

    3 months postoperative is our aim

  • pain of scrotum

    subjective sensation measured by visual analogue score preoperative and postoperative

    3 months postoperative is our aim

Study Arms (1)

pre-operative and postoperative

EXPERIMENTAL

the patients who will undergo the operation to treat the pain

Procedure: varicocelectomy

Interventions

varicocelectomyPROCEDURE

operation for varix ligation

pre-operative and postoperative

Eligibility Criteria

Age19 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Recurrent varicocele

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit Medical School

Asyut, Assuit, 71621, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 22784493BACKGROUND

  • 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.

    PMID: 24917707BACKGROUND

  • 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.

    PMID: 30990285BACKGROUND

  • Maghraby HA. Laparoscopic varicocelectomy for painful varicoceles: merits and outcomes. J Endourol. 2002 Mar;16(2):107-10. doi: 10.1089/089277902753619627.

    PMID: 11962551BACKGROUND

  • 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.

    PMID: 9554356BACKGROUND

  • 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.

    PMID: 10654904BACKGROUND

MeSH Terms

Conditions

VaricocelePainInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief resident of urology

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 12, 2020

Study Start

August 12, 2017

Primary Completion

August 12, 2020

Study Completion

August 12, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

EG(1)