Probiotics on Sperm Quality in Male Infertility Patients

Summary

This randomized, placebo-controlled pilot study aims to evaluate the effects of probiotic supplementation on sperm quality in male patients diagnosed with infertility. Male infertility accounts for approximately 40% of all infertility cases and is closely related to abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, inflammation, and DNA fragmentation are known to impact sperm function and subsequent fertilization potential negatively.

Probiotics are microorganisms that confer health benefits by improving the intestinal microenvironment and regulating immunity. Emerging research suggests that probiotics may reduce oxidative stress and DNA fragmentation in men with asthenozoospermia; however, clinical data on human sperm remains limited. This study seeks to determine whether specific probiotic strains can improve sperm parameters and function in patients with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia.

The study will enroll 60 male participants aged 20 to 45 who meet specific inclusion criteria, including a sperm concentration of less than 50 million/mL, motility less than 40%, and normal morphology (Kruger) less than 4%. Participants will be randomly assigned to either an experimental group receiving probiotics or a control group receiving a placebo for approximately 100 days.

Semen samples will be collected and analyzed at three time points: before the intervention (Day 0), during the intervention (Day 60), and at the end of the study (Day 100). The primary objective is to assess changes in sperm concentration, motility, and morphology using the Computer-Aided Sperm Analysis (CASA) system. Secondary objectives include evaluating sperm DNA integrity using the Sperm Chromatin Structure Assay (SCSA) by flow cytometry and assessing sperm function via the acrosome reaction assay. The results of this pilot study will help determine the potential therapeutic role of probiotics in the management of male infertility.

Conditions

• Male Infertility
• Oligozoospermia
• Asthenozoospermia
• Teratozoospermia
• Oligoasthenoteratozoospermia

Interventions

DIETARY_SUPPLEMENT

Probiotics

The subjects take 2 probiotic capsules after each meal daily.

DIETARY_SUPPLEMENT

Placebo

The control group takes two placebo capsules (containing no probiotics) after meals daily.

Sponsors & Collaborators

• Grape King Bio Ltd.

  collaborator INDUSTRY

• Mackay Memorial Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-16

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Taiwan

Study Locations