NCT03750370

Brief Summary

To evaluate the long-term effects of varicocelectomy on testicular arterial flow via Color Doppler Sonography Parameters; The arterial flow velocities (peak systolic velocity \[PSV\] and end diastolic velocity \[EDV\]) and the resistance indices against this flow (resistive index \[RI\] and pulsatility index \[PI\]) of the testicular artery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

November 18, 2018

Last Update Submit

January 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate testicular perfusion before and after varicocelectomy

    Evaluation of testicular perfusion is done by Comparison between Doppler sonographic Parameters Peak systolic velocity ( Cm / sec) , End diastolic velocity ( Cm / sec) , Pulsatility index , And Resistive index Values Before and after varicocelectomy Operation.

    baseline

Interventions

Colored Doppler Sonography is well established to illustrate microvascularity and therefore perfusion of the testis. The arterial flow velocities (peak systolic velocity \[PSV\] and end diastolic velocity \[EDV\]) and the resistance indices against this flow (resistive index \[RI\] and pulsatility index \[PI\]) in the testis can be measured with this technique.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Egyptian Population , Random Selection of 50 patients with varicocele in the waiting list of varicocelectomy either open or laparoscopic approaches

You may qualify if:

  • Patients with subfertility in different age groups with either unilateral or bilateral clinical varicoceles and at least one abnormal semen parameter.

You may not qualify if:

  • Patients with varicocele with normal semen parameters.
  • Fertile Patients with varicoceles seeking operation only to relieve pain and heaviness.
  • Patients with recurrent varicoceles after operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine of Assuit

Asyut, 71515, Egypt

RECRUITING

Related Publications (3)

  • Tarhan S, Ucer O, Sahin MO, Gumus B. Long-term effect of microsurgical inguinal varicocelectomy on testicular blood flow. J Androl. 2011 Jan-Feb;32(1):33-9. doi: 10.2164/jandrol.109.009977. Epub 2010 Jul 29.

    PMID: 20671143BACKGROUND
  • Zhang M, Du L, Liu Z, Qi H, Chu Q. The effects of varicocelectomy on testicular arterial blood flow: laparoscopic surgery versus microsurgery. Urol J. 2014 Nov 1;11(5):1900-6.

    PMID: 25361712BACKGROUND
  • Akand M, Koplay M, Islamoglu N, Altintas E, Kilic O, Gul M, Kulaksizoglu H, Sivri M, Goktas S. Color Doppler ultrasound characteristics after subinguinal microscopic varicocelectomy. Med Ultrason. 2017 Jan 31;19(1):59-65. doi: 10.11152/mu-920.

    PMID: 28180198BACKGROUND

MeSH Terms

Interventions

Ultrasonography, Doppler

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mahmoud Mohammad Aly, M.B.B.CH

CONTACT

Eman Abu- EL-Hamd, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

November 18, 2018

First Posted

November 23, 2018

Study Start

January 1, 2019

Primary Completion

December 1, 2019

Study Completion

April 1, 2020

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations