An interventional study of Microscopic Sub-inguinal Varicocelectomy in Varicocele, Male Infertility and Secondary Hypogonadism, sponsored by Assiut University. Not yet recruiting. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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:
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 36 interventional studies indexed under Varicocele.
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Exclusion Criteria:
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.
Procedure: Microscopic Sub-inguinal Varicocelectomy
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.
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.
No study locations are listed for this record.
Start is estimated for May 2026; primary completion for May 2027, 12 months later.
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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