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Probiotics in varicocele

The effect of Lactobacillus rhamnosus probiotic & Vitamin E on sperm parameters, oxidative stress, and testosterone level after subinguinal varicocelectomy: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260512069375N1
Enrollment
120
Registered
2026-05-14
Start date
2026-06-21
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicocele.

Interventions

Intervention 1: Recipient of the probiotic Lactobacillus rhamnosus. Intervention 2: Intervention group: Vitamin E recipient. Intervention 3: Control group: Placebo (dextrose) recipient.

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: People who refer to the Hazrat Ali Asghar Shiraz Medical Center will have their disease diagnosed by a single surgeon with Doppler ultrasound and will undergo surgery Patients must be between the ages of 18 and 45 The patient's BMI must be between 18 and 25 Clinical diagnosis must be grade two or three varicocele on the left side Patients must be candidate for subinguinal varicocelectomy

Exclusion criteria

Exclusion criteria: consumption of any kinds of antibiotics or probiotics in the past month patients with infectious diseases and AIDS Having metabolic and digestive diseases that affect fertility Having hormonal disorders History of testicular cancer History of smoking, alcohol, drugs, and psychotropic substances Special diets Allergy to probiotics Patients with azoospermia Patients with testicular atrophy

Design outcomes

Primary

MeasureTime frame
Sperm parameters (variables of semen volume, concentration, motility and sperm kinematics); sperm viability; sperm DNA fragmentation index (DFI); normal sperm morphology; sperm acrosomal reaction; oxidative stress indices (TAC, MDA, GPx, SOD and catalase); serum levels of total and free testosterone. Timepoint: Measurement of semen parameters before the start of the study and three months after taking the drug; measurement and comparison of sperm viability, sperm DNA fragmentation (DFI), with normal sperm morphology, sperm acrosome reaction, oxidative stress indicators (TAC, MDA, GPx, SOD and catalase) and serum levels of total and free testosterone after three months of taking the drug. Method of measurement: Semen analysis with a light microscope and CASA computerized sperm analyzer; sperm viability assessment with eosin staining and light microscopy; DNA structure integrity assessment using a sperm chromatin dispersion kit; sperm morphology assessment with a Diff-Quik kit; acrosome reaction assessment using FITC-PSA lectin and fluorescent microscopy with FITC filter; measurement of oxidative stress indices (TAC, MDA, GPx, SOD, and catalase) and serum levels of total and free testosterone with commercial ELISA kits.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Zarei

Shiraz University of Medical Sciences

zareimr@sums.ac.ir+98 71 3230 5410

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026