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Nitroglycerine Instillation in Loop-assisted VaricocelectomyNCT07306572

Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy

A study testing loop-assisted varicocelectomy with nitroglycerine instillation and microscopic varicocelectomy in people with Nitroglycerine Instillation in Loop-assisted Varicocelectomy and Microscopic Varicocelectomy, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men only
What is being tested?
loop-assisted varicocelectomy with nitroglycerine instillation and microscopic varicocelectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 May 2023to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mohamed Mahmoud Dogha

    Al Fayyum, 63514

Other trials in Egypt

About this study

Official title: Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy

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.

Read the detailed description

Introduction:

The dilation and anomaly of the testicular veins within the spermatic cord is known as varicocele. It is the most frequent treatable cause of male infertility and a significant contributor to poor spermatogenesis. Only 20% of males with verified varicocele, according to reports, have infertility issues . Disrupting the venous return from the pampiniform plexus's enlarged veins is the main objective of varicocele repair. The internal spermatic artery, vas deferens, and spermatic cord lymphatics are among the vital spermatic cord structures that must be preserved during surgery .

Urologists now use a variety of techniques for varicocele repair, such as inguinal, subinguinal, retroperitoneal, laparoscopic, angioembolization, and both loupe-assisted (LV) and microscopic varicocelectomy (MV) .

The results of varicocelectomy have been greatly improved by the use of surgical microscopes and loupes, and MV is now regarded as the gold standard procedure. Recurrence rates and the frequency of problems such hydrocele formation are remarkably low when done with the right expertise and experience, ranging from 1-2% and 0-1%, respectively.Vasodilators have been used in certain cases to increase vein recognition and visualize the pulse of the testicular artery during surgery, which may further improve surgical outcomes and lower complications .Compared to surgical microscopes, surgical loupes are more widely available, less expensive, and have a simpler learning curve .

Patient and methods:

After receiving clearance from the Fayoum Faculty of Medicine's ethics committee (Number -M 652) in May 2023, this study included 60 patients who were admitted to the urology department of Fayoum University Hospital and had been diagnosed with clinical varicocele that required a varicocelectomy. Using a computerized process, the patients were prospectively randomized into two groups (1:1 ratio, 30 patients each group). Nitroglycerin was administered as a vasodilator during subinguinal loupe-assisted varicocelectomy (LV) in Group A. Subinguinal microscopic varicocelectomy (MV) was performed on Group B. All patients gave their informed consent in compliance with the guidelines set forth by the Fayoum University Faculty of Medicine's ethical committee.

G*Power version 3.1.7 was used to calculate the sample size. In order to reach a power level of 0.80 at an alpha level of 0.05 (two-tailed), a minimum of 20 patients per group were first determined. A power level of 0.95 was attained by increasing the sample size to 30 patients per group to account for possible loss to follow-up. 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. The patients ranged in age from 18 to 50. Those with systemic conditions that impact arterial flow, such as diabetes, hypertension, liver disease, and hypercholesterolemia, were excluded if they were younger than 18 or older than 50.

Additionally, patients with subclinical varicocele who had previously had varicocelectomy or inguinoscrotal surgery on the same side were not included.

Every patient had a comprehensive evaluation that included a complete general, local, and genital examination as well as a detailed medical and surgical history.Prior to intervention, all patients underwent two semen analyses. Patients with severe oligospermia and azoospermia underwent hormonal analysis, and routine laboratory tests were performed prior to surgery.

Scrotal ultrasonography and color doppler ultrasonography were used in the radiological examination to measure the resistive index (RI) for the intra-testicular and capsular arteries, show the diameter of the sprematic vein, and assess the degree of reflux using the valsalva maneuver. Doppler and ultrasound evaluations were performed prior to and three months following the surgery

Operative Technique Every patient had a subinguinal varicocelectomy while under general or spinal anesthesia, when needed. Group B used a surgical microscope with ×10 to ×12 magnification, while Group A used a surgical loop (Sinirgia 3.3X expandable field) with the instillation of 1 ml nitroglycerine following the identification and incision of spermatic fascia of the cord for accurate identification of spermatic arteries and veins and prior to vein ligation. recording the entire duration of the procedure, from skin incision to closure. It was noted how many veins were ligated both inside and outside the cord. Vital sign monitoring was done during the process. Evaluation for bleeding, scrotal hematoma, and length of hospital stay were all part of postoperative surveillance. Following surgery, patients were monitored for three months. Repeat semen analysis and a scrotal Doppler evaluation three months after the intervention were part of the follow-up.

Analysis of Statistics

Statistical Analysis After the data was coded and imported into Microsoft Excel, SPSS version 29 for Windows was used for analysis. Counts, percentages, means with standard deviations for parametric data, and medians with ranges for non-parametric data were examples of descriptive statistics. The one-sample Kolmogorov-Smirnov test was used to determine whether quantitative data was normal. The Chi-square test was used to compare nominal qualitative groups, the Mann-Whitney U test was used to compare ordinal qualitative groups, the independent samples t-test was used to compare quantitative measures between independent groups, the paired t-test was used to compare dependent quantitative data, and statistical significance was set at P < 0.05.

Being tested
loop-assisted varicocelectomy with nitroglycerine instillation, microscopic varicocelectomy
Keywords
loop-assisted, microscopic, varicocelectomy, nitroglycerine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • loop-assisted varicocelectomy with nitroglycerine instillationProcedure or surgery

    nitroglycerine instillation with loop-assisted varicocelectomy

  • microscopic varicocelectomyProcedure or surgery

    we use microscopic magnification in varicocelectomy

Study groups in NCT07306572
Study groupRoleWhat they receive
loop-assisted varicocelectoy with nitroglycerin instillation groupExperimentalVaricocelectomy is done using loop to improve vision and nitroglycerine instillation to cause vessel dilation and improve identification of arteries to avoid injury
Receives: Procedure: loop-assisted varicocelectomy with nitroglycerine instillation
microscopic varicocelectomy groupActive comparatorvaricocelectomy done using microscopic assistance to improve vision
Receives: Procedure: microscopic varicocelectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percent of sperm motility in semen analysis

    percent of improvement of sperm motility

    Measured: 3 months

Secondary outcomes (1)
  1. testicular Doppler parameters, mainly percentages of resistive index changes

    percentages of changes in resistive index in testes

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start1 May 2023
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
group A where we use nitroglycerine instillation with loop-assisted varicocelectomy
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07306572
Sponsor's protocol ID
M-652
Status last verified
Dec 2025
First submitted
21 Nov 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: participant request

Questions about this trial

What is this clinical trial studying?

A study testing loop-assisted varicocelectomy with nitroglycerine instillation and microscopic varicocelectomy in people with Nitroglycerine Instillation in Loop-assisted Varicocelectomy and Microscopic Varicocelectomy, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percent of sperm motility in semen analysis (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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