Intratesticular Artery Resistive Index Changes After Varicocelectomy

April 2, 2026 updated by: Mohamed Assem Hussein, Assiut University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infertile male patients with clinically palpable varicocele (Grade I to III).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microscopic Sub-inguinal Varicocelectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-operative) and 3 months post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changes after Varicocelectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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