NCT07517952

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
May 2026Jun 2027

First Submitted

Initial submission to the registry

April 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Keywords

VaricocelectomyResistive IndexIntratesticular ArterySemen ParametersTestosteroneColor Doppler UltrasonographyMicroscopic Sub-inguinal Varicocelectomy

Outcome Measures

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.

    Baseline (pre-operative) and 3 months post-operatively.

Study Arms (1)

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.

Procedure: Microscopic Sub-inguinal Varicocelectomy

Interventions

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.

Microscopic Sub-inguinal Varicocelectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

VaricoceleInfertility, MaleHypogonadism

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesInfertilityGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Andrology, Sexology and STDs Department, Assiut University

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 8, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04