VaricoceleNCT07605351
Selective Extended Venous Stripping Versus Standard Microsurgical Varicocelectomy for Varicocele-Related Male Infertility
A study testing Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping and Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation in people with Varicocele and Male Infertility, run by Benha University at 1 site in Egypt.
Trial summary
Varicocele is a common correctable cause of male infertility and may be associated with abnormal semen parameters, impaired testicular function, and scrotal discomfort. Microsurgical subinguinal varicocelectomy is a commonly used surgical approach because it allows careful preservation of the testicular artery… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Varicocele, Male Infertility
- What is being tested?
- Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping and Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2026to 15 Jun 2028
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged 18 to 50 years.
- Couple infertility for at least 12 months.
- Clinically palpable grade I to III varicocele confirmed by physical examination.
- Abnormal semen parameters documented on at least two semen analyses performed 2 to 4 weeks apart according to World Health Organization laboratory standards.
- Female partner evaluation completed or planned, with no untreated severe female factor that would make natural conception impossible.
- Willingness to comply with postoperative follow-up at 3, 6, and 12 months.
- Written informed consent.
Who cannot join
- Azoospermia or cryptozoospermia, defined as absence of sperm in the native ejaculate on at least two baseline semen analyses, including cases in which sperm are detected only after centrifugation.
- Known clinically significant chromosomal or genetic abnormality that independently explains severe male infertility, when identified before enrollment.
- Previous varicocelectomy of the index side.
- Previous inguinal, scrotal, or retroperitoneal surgery that may alter spermatic cord anatomy.
- Subclinical varicocele only.
- Isolated scrotal pain with normal semen parameters.
Show all 14Show fewer
- Hypogonadotropic hypogonadism requiring hormonal induction therapy.
- Testosterone therapy within the previous 6 months.
- Use of anti-estrogens, gonadotropins, or aromatase inhibitors within the previous 3 months.
- Active genitourinary infection.
- Testicular tumor or history of testicular cancer.
- Severe systemic disease contraindicating surgery or anesthesia.
- Inability to provide informed consent.
- Inability or unwillingness 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
Benha University Hospital
Banhā, Qalyubia Governorate, 13511
Ahmed E Zahran, MD, 0 10 07950278 ext. +2, Ahmed.ebrahim@fmed.bu.edu.eg
About this study
Official title: Selective Extended Microsurgical Venous Stripping Versus Standard Microsurgical Subinguinal Varicocelectomy in Infertile Men With Abnormal Semen Parameters: A Prospective Randomized Controlled Trial
Varicocele is a common correctable cause of male infertility and may be associated with abnormal semen parameters, impaired testicular function, and scrotal discomfort. Microsurgical subinguinal varicocelectomy is a commonly used surgical approach because it allows careful preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels under magnification. However, persistent or recurrent varicocele may still occur after surgery, possibly because of missed or persistent venous channels.
This randomized controlled trial will compare two surgical techniques in infertile men with clinically palpable varicocele and abnormal semen parameters. Participants will be randomly assigned to either microsurgical subinguinal varicocelectomy with selective extended venous stripping or standard microsurgical subinguinal varicocelectomy with conventional vein ligation and division.
The main purpose of the study is to determine whether selective extended venous stripping reduces the rate of clinically and Doppler-confirmed persistent or recurrent varicocele at 12 months after surgery compared with the standard microsurgical technique. The study will also compare semen parameter improvement, pain improvement in participants with baseline pain, pregnancy outcomes, operative time, postoperative complications, and the need for additional treatment during 12 months of follow-up.
- Conditions
- Varicocele, Male Infertility
- Being tested
- Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping, Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation
- Keywords
- Varicocele, Male Infertility, Microsurgical Varicocelectomy, Subinguinal Varicocelectomy, Venous Stripping, Semen Analysis, Scrotal Doppler Ultrasound, Varicocele Recurrence, Abnormal Semen Parameters, Pregnancy Outcome
- Medical subject headings
- Varicocele, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous StrippingProcedure or surgery
Microsurgical subinguinal varicocelectomy performed under magnification with preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels. Favorable clinically relevant dilated veins will be dissected, mobilized, stripped over a defined segment, ligated, and divided. Veins not suitable for safe stripping will be treated by standard ligation and division.
Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein LigationProcedure or surgery
Standard microsurgical subinguinal varicocelectomy performed under magnification. Identified veins requiring treatment will be isolated, ligated, and divided while preserving the testicular artery, lymphatic channels, vas deferens, and vasal vessels. Venous stripping will not be performed.
| Study group | Role | What they receive |
|---|---|---|
| Microsurgical Varicocelectomy With Selective Extended Venous | Experimental | Participants randomized to this arm will undergo microsurgical subinguinal varicocelectomy with selective extended venous stripping. Suitable clinically relevant dilated veins will be circumferentially dissected, mobilized, stripped over a defined segment, ligated, and divided when predefined safety criteria are met. Veins unsuitable for safe stripping will be treated by standard ligation and division, with documentation of the reason for non-stripping. Receives: Procedure: Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping |
| Standard Microsurgical Subinguinal Varicocelectomy | Active comparator | Participants randomized to this arm will undergo standard microsurgical subinguinal varicocelectomy with conventional ligation and division of identified veins requiring treatment under microscopic magnification. No venous stripping will be performed. Receives: Procedure: Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent or Recurrent Varicocele on the Operated Side
Persistent or recurrent varicocele will be defined as a palpable varicocele on standing physical examination confirmed by color Doppler ultrasound showing pampiniform plexus vein diameter of at least 3.0 millimeters with reflux lasting more than 2 seconds during Valsalva maneuver. For bilateral surgery, recurrence on either operated side will be counted as recurrence.
Measured: 12 months after surgery
Secondary outcomes (12)
Change in Total Motile Sperm Count
Total motile sperm count will be calculated as semen volume multiplied by sperm concentration multiplied by total motility percentage. The mean of two baseline semen analyses will be used for baseline assessment.
Measured: Baseline and 6 months after surgery
Change in Sperm Concentration
Sperm concentration will be measured by semen analysis according to World Health Organization laboratory standards.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Total Sperm Count
Total sperm count will be measured by semen analysis according to World Health Organization laboratory standards.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Progressive Sperm Motility
Progressive sperm motility will be measured as the percentage of sperm showing progressive movement on semen analysis.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Total Sperm Motility
Total sperm motility will be measured as the percentage of motile sperm on semen analysis.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Normal Sperm Morphology
Normal sperm morphology will be measured as the percentage of sperm with normal morphology on semen analysis.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Scrotal Pain Visual Analog Scale Score Among Participants with Baseline Pain
Scrotal pain will be assessed using a 0 to 10 visual analog scale among participants who report baseline varicocele-related scrotal pain. A score of 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Baseline, 3 months, 6 months, and 12 months after surgery
Number of Couples Achieving Spontaneous Pregnancy
Spontaneous pregnancy in the female partner will be recorded during follow-up and reported separately from assisted reproductive technology-related pregnancy.
Measured: Up to 12 months after surgery
Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy
Pregnancy achieved using assisted reproductive technology will be recorded during follow-up and reported separately from spontaneous pregnancy.
Measured: Up to 12 months after surgery
Operative time
Operative time will be measured from skin incision to completion of wound closure.
Measured: Intraoperatively
Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele
Any additional surgical, radiologic, or other intervention for persistent or recurrent varicocele will be recorded.
Measured: 12 months after surgery
Number of Participants with Postoperative Complications
Postoperative complications will be recored after surgery. Complications will be graded according to the Clavien-Dindo classification of postoperative surgical complications, which classifies complications based on the treatment required, ranging from Grade I for minor deviations from normal recovery to Grade V for death.
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 randomly assigned in a one-to-one ratio to one of two parallel surgical treatment arms. One arm will undergo microsurgical subinguinal varicocelectomy with selective extended venous stripping, and the other arm will undergo standard microsurgical subinguinal varicocelectomy with conventional vein ligation and division. Participants will remain in their assigned treatment arm throughout 12 months of follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ebrahim Zahran, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605351
- Sponsor's protocol ID
- RC 12-4-2025
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data supporting the main study results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, treatment allocation, operative variables, semen analysis parameters, pain scores, Doppler ultrasound findings, pregnancy outcomes, recurrence outcomes, and postoperative complications. No directly identifying participant information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Extended Microsurgical Venous Stripping Versus Standard Microsurgical Subinguinal Varicocelectomy in Infertile Men With Abnormal Semen Parameters: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07605351
- Acronym / sponsor ID
- RC 12-4-2025
- Conditions
- Varicocele, Male Infertility
- Keywords
- Varicocele, Male Infertility, Microsurgical Varicocelectomy, Subinguinal Varicocelectomy, Venous Stripping, Semen Analysis, Scrotal Doppler Ultrasound, Varicocele Recurrence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 22 May 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.
Varicocele is a common correctable cause of male infertility and may be associated with abnormal semen parameters, impaired testicular function, and scrotal discomfort. Microsurgical subinguinal varicocelectomy is a commonly used surgical approach because it allows careful preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels under magnification. However, persistent or recurrent varicocele may still occur after surgery, possibly because of missed or persistent venous channels.
This randomized controlled trial will compare two surgical techniques in infertile men with clinically palpable varicocele and abnormal semen parameters. Participants will be randomly assigned to either microsurgical subinguinal varicocelectomy with selective extended venous stripping or standard microsurgical subinguinal varicocelectomy with conventional vein ligation and division.
The main purpose of the study is to determine whether selective extended venous stripping reduces the rate of clinically and Doppler-confirmed persistent or recurrent varicocele at 12 months after surgery compared with the standard microsurgical technique. The study will also compare semen parameter improvement, pain improvement in participants with baseline pain, pregnancy outcomes, operative time, postoperative complications, and the need for additional treatment during 12 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a one-to-one ratio to one of two parallel surgical treatment arms. One arm will undergo microsurgical subinguinal varicocelectomy with selective extended venous stripping, and the other arm will undergo standard microsurgical subinguinal varicocelectomy with conventional vein ligation and division. Participants will remain in their assigned treatment arm throughout 12 months of follow-up.
| Arm | Type | Receives |
|---|---|---|
| Microsurgical Varicocelectomy With Selective Extended Venous | Experimental | Procedure: Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous StrippingParticipants randomized to this arm will undergo microsurgical subinguinal varicocelectomy with selective extended venous stripping. Suitable clinically relevant dilated veins will be circumferentially dissected, mobilized, stripped over a defined segment, ligated, and divided when predefined safety criteria are met. Veins unsuitable for safe stripping will be treated by standard ligation and division, with documentation of the reason for non-stripping. |
| Standard Microsurgical Subinguinal Varicocelectomy | Active comparator | Procedure: Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein LigationParticipants randomized to this arm will undergo standard microsurgical subinguinal varicocelectomy with conventional ligation and division of identified veins requiring treatment under microscopic magnification. No venous stripping will be performed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male patients aged 18 to 50 years.
- Couple infertility for at least 12 months.
- Clinically palpable grade I to III varicocele confirmed by physical examination.
- Abnormal semen parameters documented on at least two semen analyses performed 2 to 4 weeks apart according to World Health Organization laboratory standards.
- Female partner evaluation completed or planned, with no untreated severe female factor that would make natural conception impossible.
Key exclusion criteria (14 listed)
- Azoospermia or cryptozoospermia, defined as absence of sperm in the native ejaculate on at least two baseline semen analyses, including cases in which sperm are detected only after centrifugation.
- Known clinically significant chromosomal or genetic abnormality that independently explains severe male infertility, when identified before enrollment.
- Previous varicocelectomy of the index side.
- Previous inguinal, scrotal, or retroperitoneal surgery that may alter spermatic cord anatomy.
- Subclinical varicocele only.
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 |
|---|---|---|
| Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous StrippingMicrosurgical subinguinal varicocelectomy performed under magnification with preservation of the testicular artery, lymphatic channels, vas deferens, and vasal vessels. Favorable clinically relevant dilated veins will be dissected, mobilized, stripped over a defined segment, ligated, and divided. Veins not suitable for safe stripping will be treated by standard ligation and division. | Procedure or surgery | Microsurgical Varicocelectomy With Selective Extended Venous |
| Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein LigationStandard microsurgical subinguinal varicocelectomy performed under magnification. Identified veins requiring treatment will be isolated, ligated, and divided while preserving the testicular artery, lymphatic channels, vas deferens, and vasal vessels. Venous stripping will not be performed. | Procedure or surgery | Standard Microsurgical Subinguinal Varicocelectomy |
Primary outcome
Persistent or Recurrent Varicocele on the Operated Side
Time frame: 12 months after surgery
Persistent or recurrent varicocele will be defined as a palpable varicocele on standing physical examination confirmed by color Doppler ultrasound showing pampiniform plexus vein diameter of at least 3.0 millimeters with reflux lasting more than 2 seconds during Valsalva maneuver. For bilateral surgery, recurrence on either operated side will be counted as recurrence.
12 secondary outcomes
Change in Total Motile Sperm Count
Time frame: Baseline and 6 months after surgery
Change in Sperm Concentration
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Total Sperm Count
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Progressive Sperm Motility
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Total Sperm Motility
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Normal Sperm Morphology
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Change in Scrotal Pain Visual Analog Scale Score Among Participants with Baseline Pain
Time frame: Baseline, 3 months, 6 months, and 12 months after surgery
Number of Couples Achieving Spontaneous Pregnancy
Time frame: Up to 12 months after surgery
Number of Couples Achieving Assisted Reproductive Technology-Related Pregnancy
Time frame: Up to 12 months after surgery
Operative time
Time frame: Intraoperatively
Number of Participants Requiring Additional Intervention for Persistent or Recurrent Varicocele
Time frame: 12 months after surgery
Number of Participants with Postoperative Complications
Time frame: Up to 12 months 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 22 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data supporting the main study results may be shared upon reasonable request. Shared data may include baseline demographic and clinical characteristics, treatment allocation, operative variables, semen analysis parameters, pain scores, Doppler ultrasound findings, pregnancy outcomes, recurrence outcomes, and postoperative complications. No directly identifying participant information will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microsurgical Subinguinal Varicocelectomy With Selective Extended Venous Stripping and Standard Microsurgical Subinguinal Varicocelectomy With Conventional Vein Ligation in people with Varicocele and Male Infertility, run by Benha 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 14 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: opening soon, as of the sponsor's last update on 22 May 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 Ahmed E Zahran, MD (+20 10 07950278 ext. +2, Ahmed.ebrahim@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent or Recurrent Varicocele on the Operated Side (time frame: 12 months after surgery). 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 22 May 2026.