Intratesticular Artery Resistive Index Changes After Varicocelectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infertile male patients with clinically palpable varicocele (Grade I to III).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Microscopic Sub-inguinal Varicocelectomy
Procedure/SurgeryThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Microscopic Sub-inguinal VaricocelectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-operative) and 3 months post-operatively.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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