An interventional study of Probiotics and Placebo in Male Infertility, Oligozoospermia and Asthenozoospermia, sponsored by Mackay Memorial Hospital. Recruiting at 1 site in Taiwan. Open to male participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Treatment
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.
Content: Male infertility accounts for approximately 40% of infertility cases and is often characterized by abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, environmental hormones, and inflammation can lead to sperm DNA fragmentation and mitochondrial dysfunction, ultimately affecting fertilization potential. While probiotics are known to improve gut microbiome balance and regulate immunity, limited studies suggest they may also improve sperm motility and reduce DNA fragmentation in men with asthenozoospermia.
This pilot study employs a randomized, placebo-controlled design to evaluate the efficacy of probiotic supplementation in improving sperm quality. A total of 60 male participants with unexplained infertility (specifically oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia) will be recruited. Participants will be divided into two groups: an experimental group receiving probiotics and a control group receiving a placebo.
The study duration for each participant is approximately 100 days, with semen samples collected at three distinct time points:
Semen analysis will be conducted using the following methodologies:
Sperm Function (Acrosome Reaction): Evaluated using Peanut Agglutinin (PNA) staining. The assay determines the percentage of sperm capable of undergoing the acrosome reaction, a necessary step for fertilization.
Inclusion Criteria
Semen Parameters:
Sperm morphology (Kruger strict criteria) \< 4%. Exclusion Criteria
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 187 interventional studies indexed under Infertility, Male.
Browse Infertility, Male studies →Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 27 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group takes probiotics, two capsules a day, after meals.
Dietary Supplement: Probiotics
The control group is given the same dosage form without probiotics (placebo), two capsules a day, after meals.
Dietary Supplement: Placebo
The subjects take 2 probiotic capsules after each meal daily.
The 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.
Time frame: Day 60, Day 100
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.
Time frame: Day 60, Day 100
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.
Time frame: Day 60, Day 100
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.
Time frame: Day 60, Day 100
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.
Time frame: Day 60, Day 100
Plan to share: Undecided
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