Actively Recruiting
Effect of Probiotics on Sperm Quality in Male Infertility Patients
Led by Mackay Memorial Hospital · Updated on 2026-01-15
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mackay Memorial Hospital
Lead Sponsor
G
Grape King Bio Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of probiotic supplements on sperm quality in men diagnosed with infertility, focusing on unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia. Male infertility, which accounts for about 40% of infertility cases, is often linked to low sperm count, poor motility, and abnormal morphology. The study explores whether probiotics can reduce oxidative stress and DNA fragmentation that negatively affect sperm function and fertilization potential. The study is a randomized, placebo-controlled pilot trial involving 60 male participants aged 20 to 45 years. Participants are randomly assigned to receive either probiotics or a placebo, taking two capsules daily after meals for approximately 100 days. Semen samples are collected at the start, mid-point (Day 60), and end (Day 100) of the intervention to assess sperm concentration, motility, morphology, DNA integrity, and function. During the study, sperm concentration, motility, and morphology are measured using Computer-Aided Sperm Analysis (CASA). Secondary assessments include sperm DNA fragmentation measured by the Sperm Chromatin Structure Assay (SCSA) and sperm function evaluated by the acrosome reaction assay. These tests help determine changes over time. The study includes careful monitoring and aims to clarify probiotics' potential role in improving male infertility. Participation lasts about 100 days with sample collections and evaluations at three specific time points.
CONDITIONS
Brief Title
Probiotics on Sperm Quality in Male Infertility Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males aged 20 to 45 years
- Diagnosed with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia
- Sperm concentration less than 5 x 10^6/mL
- Sperm total motility less than 40%
- Sperm morphology (Kruger strict criteria) less than 4%
You will not qualify if you...
- 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
- Chronic liver disease
- Varicocele
- Current use of medications that interfere with hormones
- Occupational or environmental exposure to pesticides, heavy metals, or solvents
- Intake of antioxidant supplements within the past three months
- Body Mass Index (BMI) of 30 kg/m^2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 100 days
Participants take either probiotic capsules or placebo capsules daily to evaluate the effect on sperm quality.
3 visits (Day 0, Day 60, Day 100) for semen sample collection
Trial Site Locations
Total: 1 location
1
MacKay Memorial Hospital
New Taipei City, Taiwan, 25160
Actively Recruiting
Research Team
S
Sheng-Hsiang Li, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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