Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy

NCT07306572 | Completed DMC

• 1 other identifier: M-652
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Goal: To evaluate the safety and effectiveness of subinguinal microscopic varicocelectomy versus subinguinal loupe-assisted varicocelectomy with nitroglycerin instillation as a vasodilator. Materials and Procedures: 60 patients were enrolled in our prospective randomized trial between May 2023 and April 2024. They were split into two groups, Group A undergoing Loupe varicocelectomy (LV) with nitroglycerin instillation, and Group B undergoing Microscopic varicocelectomy (MV). Nitroglycerin was administered to the LV group following delivery and cord incision to help visualize cord veins and arterial pulse and avoid confusion with other cord structures that were to be preserved. Three months after the procedure, both groups had scrotal Doppler and semen analysis.

Conditions

Nitroglycerine Instillation in Loop-assisted Varicocelectomy; Microscopic Varicocelectomy

Keywords

loop-assisted; microscopic; varicocelectomy; nitroglycerine

Outcome Measures

Primary Outcomes (1)

• percent of sperm motility in semen analysis

  percent of improvement of sperm motility

  3 months

Secondary Outcomes (1)

• testicular Doppler parameters, mainly percentages of resistive index changes

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

loop-assisted varicocelectoy with nitroglycerin instillation group

EXPERIMENTAL

Varicocelectomy is done using loop to improve vision and nitroglycerine instillation to cause vessel dilation and improve identification of arteries to avoid injury

Procedure: loop-assisted varicocelectomy with nitroglycerine instillation

microscopic varicocelectomy group

ACTIVE COMPARATOR

varicocelectomy done using microscopic assistance to improve vision

Procedure: microscopic varicocelectomy

Interventions

loop-assisted varicocelectomy with nitroglycerine instillation PROCEDURE

nitroglycerine instillation with loop-assisted varicocelectomy

loop-assisted varicocelectoy with nitroglycerin instillation group

microscopic varicocelectomy PROCEDURE

we use microscopic magnification in varicocelectomy

microscopic varicocelectomy group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with clinically evident varicocele who presented with primary or secondary infertility
• intractable pain
• aberrant semen values
• and diminished testicular volume were included in the study.

You may not qualify if:

• Those with systemic conditions that impact arterial flow, such as diabetes, hypertension, liver disease, and hypercholesterolemia
• Younger than 18 or older than 50.
• Patients with subclinical varicocele
• patients had previously had a varicocelectomy or inguinoscrotal surgery on the same side were not included.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Mohamed Mahmoud Dogha

Al Fayyum, 63514, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of urology

Model Details: group A where we use nitroglycerine instillation with loop-assisted varicocelectomy

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 29, 2025
• Study Start: May 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)