NCT06743932

Brief Summary

Traditional surgical ligation of the spermatic cord veins is effective in reducing the size of the varicocele and improving fertility outcomes. However, this procedure can be associated with complications such as hydrocele formation and recurrence . Antegrade sclerotherapy offers a minimally invasive alternative, involving the injection of a sclerosing agent directly into the dilated veins to achieve occlusion and reduce reflux . This study aims to optimize treatment outcomes for varicocele by combining the benefits of surgical ligation with the sclerosing effects of sclerotherapy .The primary goal is to evaluate the efficacy and safety of combining antegrade sclerotherapy and surgical ligation in the treatment of varicocele .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

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

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 17, 2024

Last Update Submit

December 17, 2024

Conditions

Keywords

LigationSclerotherapy

Outcome Measures

Primary Outcomes (1)

  • varicocele grade

    Assess the change in varicocele grade from baseline to post-treatment using clinical examination and/or ultrasound

    30 day

Study Arms (1)

varicocel patients

varicocele patients will be follow up after Ligation and Sclerotherapy

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

varicocele patients withClinically and Doppler confirmed grades II or III varicocele.

You may qualify if:

  • Clinically and Doppler confirmed grades II or III varicocele. 2- All left, right or bilateral side varicocele. 3- Testicular pain or testicular atrophy. 4- Presence of at least one impaired semen parameter. 5- Age more than 18years

You may not qualify if:

  • Pre-existing hydrocele. 2- Concomitant hernia 3- Previous inguinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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
  • Su JS, Farber NJ, Vij SC. Pathophysiology and treatment options of varicocele: An overview. Andrologia. 2021 Feb;53(1):e13576. doi: 10.1111/and.13576. Epub 2020 Apr 9.

    PMID: 32271477BACKGROUND

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mohamed Mostafa Khedr, resident doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Assiut University hospital

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

December 20, 2024

Record last verified: 2024-12