VaricoceleNCT07517952
Intratesticular Artery Resistive Index Changes After Varicocelectomy
A study testing Microscopic Sub-inguinal Varicocelectomy in people with Varicocele and Male Infertility, run by Assiut University.
Trial summary
This study aims to evaluate how blood flow inside the testicles changes after surgery to correct a varicocele, and whether these changes correlate with improvements in semen quality and testosterone levels. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Varicocele, Male Infertility, Secondary Hypogonadism
- What is being tested?
- Microscopic Sub-inguinal Varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infertile male patients with clinically palpable varicocele (Grade I to III).
Who cannot join
- Extremes of age (pediatric or geriatric populations).
- History of previous scrotal surgery or trauma.
- Active urogenital infection (e.g., epididymo-orchitis).
- History of testicular torsion.
- Any comorbidity that may independently affect testicular vascularity or hemodynamics.
About this study
Official title: Evaluation of Changes in Intratesticular Artery Resistive Index Following Varicocelectomy and Their Correlation With Semen Parameters and Testosterone Levels
This study aims to evaluate how blood flow inside the testicles changes after surgery to correct a varicocele, and whether these changes correlate with improvements in semen quality and testosterone levels.
Varicocele is a common, treatable cause of male infertility that can negatively affect testicular function by altering blood flow and temperature. While surgery (varicocelectomy) often improves fertility, doctors are continually looking for ways to predict which patients will benefit the most from the procedure. This study uses scrotal color Doppler ultrasound to measure the Intratesticular Artery Resistive Index (RI), which is an indicator of blood flow resistance and microvascular health, before and after surgery.
Read more
Researchers will recruit 40 infertile men with clinically palpable varicoceles. Participants will undergo a baseline evaluation that includes a physical exam, semen analysis, a blood test for total testosterone, and a specialized ultrasound to measure the RI under different physical conditions (lying down, standing, and during a Valsalva maneuver/bearing down).
All participants will then undergo a microscopic sub-inguinal varicocelectomy, which is the standard microsurgical treatment. Three months after the surgery, participants will return for follow-up testing to repeat the semen analysis, testosterone blood test, and ultrasound.
The main goal of the study is to determine if pre-operative RI measurements can serve as an early, reliable predictor of surgical success, specifically looking at the recovery of testicular function, sperm parameters, and hormonal levels.
Read the detailed description
Varicocele is a highly prevalent cause of male infertility, estimated to affect up to 40% of men presenting with infertility. It disrupts the thermoregulatory and hemodynamic environment of the testis, leading to mechanisms such as hyperthermia, hypoxia, impaired blood flow, and the backflow of adrenal metabolites. These factors collectively cause dysfunction in both Sertoli and Leydig cells. Consequently, varicocele is recognized as a significant cause of secondary hypogonadism, resulting in reduced serum testosterone levels alongside impaired spermatogenesis and reduced sperm morphological integrity.
Scrotal color Doppler ultrasonography (CDUS) is a critical tool for assessing testicular vascular perfusion. The Resistive Index (RI), calculated from the peak systolic and end-diastolic velocities of the intratesticular and capsular arteries, serves as a reliable indicator of parenchymal microperfusion and microvascular integrity. Elevated RI values in varicocele patients reflect impaired microvascularization and significantly reduced testicular perfusion.
To evaluate the predictive value of RI on surgical outcomes, this study utilizes a highly standardized assessment protocol at baseline and at a 3-month post-operative follow-up:
- Semen Analysis: Evaluations are conducted in strict accordance with the WHO Laboratory Manual for the Examination and Processing of Human Semen, 6th edition (2021). Samples are collected after an abstinence period of 2-7 days and analyzed within 60 minutes of collection.
- Hormonal Assessment: Serum Total Testosterone is measured using a standardized immunoassay technique. To ensure reproducibility and minimize the influence of diurnal hormonal variation, all blood samples are collected via venipuncture following an overnight fast, strictly between 8:00 AM and 10:00 AM.
- Specialized CDUS Protocol: To eliminate inter-observer variability, all ultrasound examinations are performed by a single experienced radiologist utilizing the LOGIQ P7 system (GE Healthcare) equipped with a high-frequency linear transducer. The core of the investigation involves measuring the intratesticular artery RI using pulsed-wave Doppler under four distinct, standardized physiological conditions: supine at rest, supine during a Valsalva maneuver, standing at rest (after a 3-minute pooling period), and standing during a Valsalva maneuver. Testicular volume is also calculated using the ellipsoid formula.
- Conditions
- Varicocele, Male Infertility, Secondary Hypogonadism
- Being tested
- Microscopic Sub-inguinal Varicocelectomy
- Keywords
- Varicocelectomy, Resistive Index, Intratesticular Artery, Semen Parameters, Testosterone, Color Doppler Ultrasonography, Microscopic Sub-inguinal Varicocelectomy
- Medical subject headings
- Varicocele, Infertility, Male, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic Sub-inguinal VaricocelectomyProcedure or surgery
The procedure involves making a sub-inguinal incision just below the external inguinal ring. Using an operating microscope, the spermatic cord is carefully isolated and systematically dissected. All internal spermatic veins are identified and ligated. Meticulous care is taken to preserve the testicular artery and its branches, the cremasteric artery, the vasal artery, the vas deferens, and lymphatic vessels to minimize the risk of post-operative complications such as hydrocele formation.
| Study group | Role | What they receive |
|---|---|---|
| Microscopic Sub-inguinal Varicocelectomy | Experimental | Participants in this single-arm study consist of infertile male patients with clinically palpable varicocele (Grades I to III). All participants assigned to this arm will undergo the study intervention, which is a microscopic sub-inguinal varicocelectomy. The surgical procedure involves a sub-inguinal incision and the use of an operating microscope to carefully isolate the spermatic cord and ligate all internal spermatic veins while preserving the testicular artery, vas deferens, and lymphatic vessels. Receives: Procedure: Microscopic Sub-inguinal Varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intratesticular Artery Resistive Index (RI)
The Intratesticular Artery Resistive Index (RI) is assessed using scrotal color Doppler ultrasonography. It is calculated from the peak systolic and end-diastolic velocities of the intratesticular and capsular arteries to evaluate testicular parenchymal microperfusion and vascular impedance. Measurements are taken under standardized physiological conditions.
Measured: Baseline (pre-operative) and 3 months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (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 Assiut 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Assem Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517952
- Sponsor's protocol ID
- Changes after Varicocelectomy
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Intratesticular Artery Resistive Index Following Varicocelectomy and Their Correlation With Semen Parameters and Testosterone Levels
- ClinicalTrials.gov ID
- NCT07517952
- Acronym / sponsor ID
- Changes after Varicocelectomy
- Conditions
- Varicocele, Male Infertility, Secondary Hypogonadism
- Keywords
- Varicocelectomy, Resistive Index, Intratesticular Artery, Semen Parameters, Testosterone, Color Doppler Ultrasonography, Microscopic Sub-inguinal Varicocelectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Apr 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.
This study aims to evaluate how blood flow inside the testicles changes after surgery to correct a varicocele, and whether these changes correlate with improvements in semen quality and testosterone levels.
Varicocele is a common, treatable cause of male infertility that can negatively affect testicular function by altering blood flow and temperature. While surgery (varicocelectomy) often improves fertility, doctors are continually looking for ways to predict which patients will benefit the most from the procedure. This study uses scrotal color Doppler ultrasound to measure the Intratesticular Artery Resistive Index (RI), which is an indicator of blood flow resistance and microvascular health, before and after surgery.
Researchers will recruit 40 infertile men with clinically palpable varicoceles. Participants will undergo a baseline evaluation that includes a physical exam, semen analysis, a blood test for total testosterone, and a specialized ultrasound to measure the RI under different physical conditions (lying down, standing, and during a Valsalva maneuver/bearing down).
All participants will then undergo a microscopic sub-inguinal varicocelectomy, which is the standard microsurgical treatment. Three months after the surgery, participants will return for follow-up testing to repeat the semen analysis, testosterone blood test, and ultrasound.
The main goal of the study is to determine if pre-operative RI measurements can serve as an early, reliable predictor of surgical success, specifically looking at the recovery of testicular function, sperm parameters, and hormonal levels.
Detailed description
Varicocele is a highly prevalent cause of male infertility, estimated to affect up to 40% of men presenting with infertility. It disrupts the thermoregulatory and hemodynamic environment of the testis, leading to mechanisms such as hyperthermia, hypoxia, impaired blood flow, and the backflow of adrenal metabolites. These factors collectively cause dysfunction in both Sertoli and Leydig cells. Consequently, varicocele is recognized as a significant cause of secondary hypogonadism, resulting in reduced serum testosterone levels alongside impaired spermatogenesis and reduced sperm morphological integrity.
Scrotal color Doppler ultrasonography (CDUS) is a critical tool for assessing testicular vascular perfusion. The Resistive Index (RI), calculated from the peak systolic and end-diastolic velocities of the intratesticular and capsular arteries, serves as a reliable indicator of parenchymal microperfusion and microvascular integrity. Elevated RI values in varicocele patients reflect impaired microvascularization and significantly reduced testicular perfusion.
To evaluate the predictive value of RI on surgical outcomes, this study utilizes a highly standardized assessment protocol at baseline and at a 3-month post-operative follow-up:
- Semen Analysis: Evaluations are conducted in strict accordance with the WHO Laboratory Manual for the Examination and Processing of Human Semen, 6th edition (2021). Samples are collected after an abstinence period of 2-7 days and analyzed within 60 minutes of collection.
- Hormonal Assessment: Serum Total Testosterone is measured using a standardized immunoassay technique. To ensure reproducibility and minimize the influence of diurnal hormonal variation, all blood samples are collected via venipuncture following an overnight fast, strictly between 8:00 AM and 10:00 AM.
- Specialized CDUS Protocol: To eliminate inter-observer variability, all ultrasound examinations are performed by a single experienced radiologist utilizing the LOGIQ P7 system (GE Healthcare) equipped with a high-frequency linear transducer. The core of the investigation involves measuring the intratesticular artery RI using pulsed-wave Doppler under four distinct, standardized physiological conditions: supine at rest, supine during a Valsalva maneuver, standing at rest (after a 3-minute pooling period), and standing during a Valsalva maneuver. Testicular volume is also calculated using the ellipsoid formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microscopic Sub-inguinal Varicocelectomy | Experimental | Procedure: Microscopic Sub-inguinal VaricocelectomyParticipants in this single-arm study consist of infertile male patients with clinically palpable varicocele (Grades I to III). All participants assigned to this arm will undergo the study intervention, which is a microscopic sub-inguinal varicocelectomy. The surgical procedure involves a sub-inguinal incision and the use of an operating microscope to carefully isolate the spermatic cord and ligate all internal spermatic veins while preserving the testicular artery, vas deferens, and lymphatic vessels. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Infertile male patients with clinically palpable varicocele (Grade I to III).
Key exclusion criteria (5 listed)
- Extremes of age (pediatric or geriatric populations).
- History of previous scrotal surgery or trauma.
- Active urogenital infection (e.g., epididymo-orchitis).
- History of testicular torsion.
- Any comorbidity that may independently affect testicular vascularity or hemodynamics.
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 |
|---|---|---|
| Microscopic Sub-inguinal VaricocelectomyThe procedure involves making a sub-inguinal incision just below the external inguinal ring. Using an operating microscope, the spermatic cord is carefully isolated and systematically dissected. All internal spermatic veins are identified and ligated. Meticulous care is taken to preserve the testicular artery and its branches, the cremasteric artery, the vasal artery, the vas deferens, and lymphatic vessels to minimize the risk of post-operative complications such as hydrocele formation. | Procedure or surgery | Microscopic Sub-inguinal Varicocelectomy |
Primary outcome
Change in Intratesticular Artery Resistive Index (RI)
Time frame: Baseline (pre-operative) and 3 months post-operatively.
The Intratesticular Artery Resistive Index (RI) is assessed using scrotal color Doppler ultrasonography. It is calculated from the peak systolic and end-diastolic velocities of the intratesticular and capsular arteries to evaluate testicular parenchymal microperfusion and vascular impedance. Measurements are taken under standardized physiological conditions.
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 8 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microscopic Sub-inguinal Varicocelectomy in people with Varicocele and Male Infertility, run by Assiut University.
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 1 inclusion and 5 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Intratesticular Artery Resistive Index (RI) (time frame: Baseline (pre-operative) and 3 months post-operatively.). 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 8 Apr 2026.