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.
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
- Conditions the study is for
- Nitroglycerine Instillation in Loop-assisted Varicocelectomy, Microscopic Varicocelectomy
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: loop-assisted varicocelectomy with nitroglycerine instillation |
| microscopic varicocelectomy group | Active comparator | varicocelectomy 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.
percent of sperm motility in semen analysis
percent of improvement of sperm motility
Measured: 3 months
Secondary outcomes (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.
- First posted29 Dec 2025
- Study start1 May 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitroglycerine Instillation in Loop-assisted VaricocelectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Dogha, Fayoum University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy
- ClinicalTrials.gov ID
- NCT07306572
- Acronym / sponsor ID
- M-652
- Keywords
- loop-assisted, microscopic, varicocelectomy, nitroglycerine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group A where we use nitroglycerine instillation with loop-assisted varicocelectomy
| Arm | Type | Receives |
|---|---|---|
| loop-assisted varicocelectoy with nitroglycerin instillation group | Experimental | Procedure: loop-assisted varicocelectomy with nitroglycerine instillationVaricocelectomy is done using loop to improve vision and nitroglycerine instillation to cause vessel dilation and improve identification of arteries to avoid injury |
| microscopic varicocelectomy group | Active comparator | Procedure: microscopic varicocelectomyvaricocelectomy done using microscopic assistance to improve vision |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loop-assisted varicocelectomy with nitroglycerine instillationnitroglycerine instillation with loop-assisted varicocelectomy | Procedure or surgery | loop-assisted varicocelectoy with nitroglycerin instillation group |
| microscopic varicocelectomywe use microscopic magnification in varicocelectomy | Procedure or surgery | microscopic varicocelectomy group |
Primary outcome
percent of sperm motility in semen analysis
Time frame: 3 months
percent of improvement of sperm motility
1 secondary outcome
testicular Doppler parameters, mainly percentages of resistive index changes
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. participant request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.