Bilateral VaricoceleNCT07650955
Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy
A study testing Single Infrapubic Microsurgical Bilateral Varicocelectomy and Bilateral Subinguinal Microsurgical Varicocelectomy in people with Bilateral Varicocele and Male Infertility, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Bilateral varicocele is commonly treated by microsurgical varicocelectomy. The conventional bilateral subinguinal approach usually requires two separate skin incisions, one on each side. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Bilateral Varicocele, Male Infertility
- What is being tested?
- Single Infrapubic Microsurgical Bilateral Varicocelectomy and Bilateral Subinguinal Microsurgical Varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged 18 to 45 years.
- Clinically palpable bilateral varicocele, grade II or grade III.
- Diagnosis confirmed by color Doppler ultrasound.
- Infertility for at least 12 months and/or abnormal semen analysis.
- Female partner evaluation performed or planned to exclude major uncorrected female-factor infertility.
- Patient fit for surgery and anesthesia.
- Written informed consent provided by the participant.
Who cannot join
- Subclinical varicocele detected only by Doppler ultrasound.
- Unilateral varicocele.
- Recurrent varicocele after previous surgery, embolization, or sclerotherapy.
- Previous inguinal, scrotal, pelvic, or penile surgery likely to distort surgical anatomy.
- Associated inguinal hernia, hydrocele, spermatocele, epididymal cyst, or other scrotal condition requiring simultaneous surgery.
- Azoospermia, especially suspected non-obstructive azoospermia.
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- Active urinary tract or genital infection.
- Coagulopathy or anticoagulant therapy that cannot be safely interrupted.
- Severe obesity, defined as body mass index greater than 40 kg/m², or any anatomical condition preventing safe exposure by either surgical approach.
- Refusal to participate or inability to complete follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, 02456
Hany F Badawy, MD, +201149525028, HANYFATHY86@GMAIL.COM
HANYFATHY86@GMAIL.COM
About this study
Official title: Single Infrapubic Versus Bilateral Subinguinal Approaches for Bilateral Microsurgical Varicocelectomy: A Prospective Randomized Controlled Trial
Bilateral varicocele is commonly treated by microsurgical varicocelectomy. The conventional bilateral subinguinal approach usually requires two separate skin incisions, one on each side. A single midline infrapubic approach may allow bilateral microsurgical repair through one incision and may reduce access-related morbidity.
This prospective randomized controlled trial will compare single infrapubic microsurgical bilateral varicocelectomy with conventional bilateral subinguinal microsurgical varicocelectomy in adult men with clinically palpable bilateral varicocele. The study will evaluate postoperative pain, analgesic requirement, time to return to normal daily activity, operative time, scar satisfaction, wound complications, recurrence, and other safety outcomes during follow-up.
- Conditions
- Bilateral Varicocele, Male Infertility
- Being tested
- Single Infrapubic Microsurgical Bilateral Varicocelectomy, Bilateral Subinguinal Microsurgical Varicocelectomy
- Keywords
- Microsurgical varicocelectomy, Single infrapubic approach, Bilateral varicocele
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Infrapubic Microsurgical Bilateral VaricocelectomyProcedure or surgery
Bilateral microsurgical varicocelectomy performed through a single midline infrapubic skin incision. The right and left spermatic cords will be approached sequentially through the same incision under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels.
Bilateral Subinguinal Microsurgical VaricocelectomyProcedure or surgery
Conventional bilateral microsurgical varicocelectomy performed through two separate standard subinguinal incisions, one on each side. Each spermatic cord will be isolated at the subinguinal level under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels.
| Study group | Role | What they receive |
|---|---|---|
| Single Infrapubic Microsurgical Bilateral Varicocelectomy | Experimental | Participants allocated to this arm will undergo bilateral microsurgical varicocelectomy through a single midline infrapubic skin incision. The right and left spermatic cords will be approached sequentially through the same incision under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels. Receives: Procedure: Single Infrapubic Microsurgical Bilateral Varicocelectomy |
| Bilateral Subinguinal Microsurgical Varicocelectomy | Active comparator | Participants allocated to this arm will undergo conventional bilateral subinguinal microsurgical varicocelectomy through two separate standard subinguinal incisions, one on each side. Each spermatic cord will be isolated at the subinguinal level under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels. Receives: Procedure: Bilateral Subinguinal Microsurgical Varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Postoperative pain will be assessed using the Visual Analog Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse postoperative pain.
Measured: 6 hours, 24 hours, and 7 days after surgery
Analgesic Requirement
Analgesic requirement will be assessed by recording the total number and dose of analgesic tablets and/or injections consumed by the participant during the first 7 postoperative days. Higher analgesic use indicates greater postoperative analgesic requirement.
Measured: During the first 7 postoperative days
Time to Return to Normal Daily Activity
Time to return to normal daily activity will be defined as the number of days from surgery until the participant resumes usual non-strenuous daily activities. A shorter time indicates faster postoperative recovery.
Measured: From surgery until return to normal daily activity, assessed up to 30 days after surgery
Total Operative Time
Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes.
Measured: During surgery
Secondary outcomes (4)
Scar Satisfaction and Cosmetic Outcome
Scar satisfaction and cosmetic outcome will be assessed using the Patient and Observer Scar Assessment Scale version 2.0. The scale includes two components: the Patient Scale and the Observer Scale. The Patient Scale assesses pain, itching, color, stiffness, thickness, and irregularity. The Observer Scale assesses vascularity, pigmentation, thickness, relief, pliability, and surface area. Each item is scored from 1 to 10, where 1 indicates normal skin or no symptoms and 10 indicates the worst imaginable scar or the greatest difference from normal skin. The total score for each component ranges from 6 to 60. Higher scores indicate worse scar quality and lower scar satisfaction.
Measured: 6 months after surgery
Varicocele Recurrence
Varicocele recurrence will be assessed by clinical examination and/or color Doppler ultrasound. Recurrence will be reported as the number and percentage of participants with recurrent varicocele.
Measured: 6 months after surgery
Conversion or Access Failure
Conversion or access failure will be recorded when the allocated surgical approach cannot be completed as planned and an additional or alternative incision or approach is required to safely complete the procedure.
Measured: During surgery
Wound Complications
Wound complications will be assessed by recording the occurrence of surgical site infection, hematoma, seroma, wound dehiscence, or delayed wound healing. The outcome will be reported as the number and percentage of participants with any wound complication.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start8 Jun 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral VaricoceleStudies 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
- Participants will be randomized in a 1:1 ratio to either single infrapubic microsurgical bilateral varicocelectomy or bilateral subinguinal microsurgical varicocelectomy.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
- Investigators
- Hany F Badawy, MD, Principal investigator, Faculty of medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650955
- Sponsor's protocol ID
- BSU-INFRAP-VARICO-2026
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes sensitive reproductive health data, semen analysis results, infertility-related information, and treatment-related clinical information. Only aggregated, de-identified results will be reported in publications or presentations. Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Infrapubic Versus Bilateral Subinguinal Approaches for Bilateral Microsurgical Varicocelectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07650955
- Acronym / sponsor ID
- BSU-INFRAP-VARICO-2026
- Conditions
- Bilateral Varicocele, Male Infertility
- Keywords
- Microsurgical varicocelectomy, Single infrapubic approach, Bilateral varicocele
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Jun 2026 (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.
Bilateral varicocele is commonly treated by microsurgical varicocelectomy. The conventional bilateral subinguinal approach usually requires two separate skin incisions, one on each side. A single midline infrapubic approach may allow bilateral microsurgical repair through one incision and may reduce access-related morbidity.
This prospective randomized controlled trial will compare single infrapubic microsurgical bilateral varicocelectomy with conventional bilateral subinguinal microsurgical varicocelectomy in adult men with clinically palpable bilateral varicocele. The study will evaluate postoperative pain, analgesic requirement, time to return to normal daily activity, operative time, scar satisfaction, wound complications, recurrence, and other safety outcomes during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either single infrapubic microsurgical bilateral varicocelectomy or bilateral subinguinal microsurgical varicocelectomy.
| Arm | Type | Receives |
|---|---|---|
| Single Infrapubic Microsurgical Bilateral Varicocelectomy | Experimental | Procedure: Single Infrapubic Microsurgical Bilateral VaricocelectomyParticipants allocated to this arm will undergo bilateral microsurgical varicocelectomy through a single midline infrapubic skin incision. The right and left spermatic cords will be approached sequentially through the same incision under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels. |
| Bilateral Subinguinal Microsurgical Varicocelectomy | Active comparator | Procedure: Bilateral Subinguinal Microsurgical VaricocelectomyParticipants allocated to this arm will undergo conventional bilateral subinguinal microsurgical varicocelectomy through two separate standard subinguinal incisions, one on each side. Each spermatic cord will be isolated at the subinguinal level under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male patients aged 18 to 45 years.
- Clinically palpable bilateral varicocele, grade II or grade III.
- Diagnosis confirmed by color Doppler ultrasound.
- Infertility for at least 12 months and/or abnormal semen analysis.
- Female partner evaluation performed or planned to exclude major uncorrected female-factor infertility.
Key exclusion criteria (10 listed)
- Subclinical varicocele detected only by Doppler ultrasound.
- Unilateral varicocele.
- Recurrent varicocele after previous surgery, embolization, or sclerotherapy.
- Previous inguinal, scrotal, pelvic, or penile surgery likely to distort surgical anatomy.
- Associated inguinal hernia, hydrocele, spermatocele, epididymal cyst, or other scrotal condition requiring simultaneous surgery.
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 |
|---|---|---|
| Single Infrapubic Microsurgical Bilateral VaricocelectomyBilateral microsurgical varicocelectomy performed through a single midline infrapubic skin incision. The right and left spermatic cords will be approached sequentially through the same incision under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels. | Procedure or surgery | Single Infrapubic Microsurgical Bilateral Varicocelectomy |
| Bilateral Subinguinal Microsurgical VaricocelectomyConventional bilateral microsurgical varicocelectomy performed through two separate standard subinguinal incisions, one on each side. Each spermatic cord will be isolated at the subinguinal level under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels. | Procedure or surgery | Bilateral Subinguinal Microsurgical Varicocelectomy |
Primary outcome
Postoperative Pain Score
Time frame: 6 hours, 24 hours, and 7 days after surgery
Postoperative pain will be assessed using the Visual Analog Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse postoperative pain.
Analgesic Requirement
Time frame: During the first 7 postoperative days
Analgesic requirement will be assessed by recording the total number and dose of analgesic tablets and/or injections consumed by the participant during the first 7 postoperative days. Higher analgesic use indicates greater postoperative analgesic requirement.
Time to Return to Normal Daily Activity
Time frame: From surgery until return to normal daily activity, assessed up to 30 days after surgery
Time to return to normal daily activity will be defined as the number of days from surgery until the participant resumes usual non-strenuous daily activities. A shorter time indicates faster postoperative recovery.
Total Operative Time
Time frame: During surgery
Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes.
4 secondary outcomes
Scar Satisfaction and Cosmetic Outcome
Time frame: 6 months after surgery
Varicocele Recurrence
Time frame: 6 months after surgery
Conversion or Access Failure
Time frame: During surgery
Wound Complications
Time frame: Up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes sensitive reproductive health data, semen analysis results, infertility-related information, and treatment-related clinical information. Only aggregated, de-identified results will be reported in publications or presentations. Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.
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.
Hany F Badawy, MD principal investigator
Faculty of medicine Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Infrapubic Microsurgical Bilateral Varicocelectomy and Bilateral Subinguinal Microsurgical Varicocelectomy in people with Bilateral Varicocele and Male Infertility, run by Beni-Suef University 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany F Badawy, MD (+201149525028, HANYFATHY86@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (time frame: 6 hours, 24 hours, and 7 days after surgery). The study lists 4 primary outcomes in all. 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 16 Jun 2026.