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.
Males aged 20 to 45 years
Diagnosis of unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia
Sperm concentration < 5 x 10^6/mL
Sperm total motility < 40%
History of hormonal disorders or epididymo-orchitis
Substance abuse, including drugs or excessive alcohol consumption
Diabetes mellitus
Kidney disease (defined as a doubling of creatinine levels or more)
Parallel
Probiotics
Dietary supplementThe subjects take 2 probiotic capsules after each meal daily.
Placebo
Dietary supplementThe control group takes two placebo capsules (containing no probiotics) after meals daily.
Change From Baseline in Sperm Concentration Assessed by Computer-Aided Sperm Analysis (CASA)
Sperm concentration (million/mL) will be measured using the Computer-Aided Sperm Analysis (CASA) system. The change from Baseline (Day 0) to subsequent time points will be calculated.
Change From Baseline in Total Sperm Motility Percentage Assessed by Computer-Aided Sperm Analysis (CASA)
The percentage of total motile sperm will be measured using the Computer-Aided Sperm Analysis (CASA) system. The change from Baseline (Day 0) to subsequent time points will be calculated.
Change From Baseline in Percentage of Normal Sperm Morphology Assessed by Computer-Aided Sperm Analysis (CASA)
The percentage of sperm with normal morphology will be measured based on Kruger strict criteria using the Computer-Aided Sperm Analysis (CASA) system. The change from Baseline (Day 0) will be calculated.
Change From Baseline in Sperm DNA Fragmentation Index (DFI) Assessed by SCSA
Sperm DNA integrity will be assessed using the Sperm Chromatin Structure Assay (SCSA) via flow cytometry. Sperm are stained with acridine orange. The result is expressed as the DNA Fragmentation Index (DFI), representing the ratio of red fluorescence (fragmented DNA) to total fluorescence (red + green). A lower DFI indicates better DNA integrity.
Change From Baseline in Sperm Acrosome Reaction Rate Assessed by PNA Staining
Sperm function will be evaluated by the acrosome reaction assay using peanut agglutinin (PNA) staining. The percentage of sperm that have undergone the acrosome reaction (indicated by specific staining patterns observed under a fluorescence microscope) will be calculated. This measures the sperm's physiological capability to fertilize an egg.
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Mackay Memorial Hospital
Lead sponsor
Grape King Bio Ltd.
Collaborator
