Probiotics to improve sperm count, motility, and morphology in men with low sperm quality
Effect of Probiotics on Sperm Quality in Male Infertility Patients
NA · Mackay Memorial Hospital · NCT07345455
This study tests whether daily probiotic supplements can improve sperm count, motility, and morphology in men with unexplained low sperm quality.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Male |
| Sponsor | Mackay Memorial Hospital (other) |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT07345455 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled pilot trial enrolling 60 men with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia. Participants receive either a probiotic supplement or placebo for about 100 days with semen samples collected at baseline (day 0), mid-intervention (day 60), and post-intervention (day 100). Sperm concentration, motility, and morphology will be measured using computer-aided sperm analysis (CASA) alongside tests for DNA fragmentation and other sperm function markers. The trial tests whether probiotic modulation of the gut and immune environment can translate into measurable improvements in sperm parameters.
Who should consider this trial
Good fit: Men aged 20–45 with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia who meet sperm criteria (sperm concentration less than 5 million/mL, total motility under 40%, Kruger morphology under 4%) and without excluded medical or exposure histories are ideal candidates.
Not a fit: Men with known causes of infertility such as varicocele, hormonal disorders, diabetes, chronic liver or kidney disease, significant occupational toxin exposure, recent antioxidant use, BMI ≥ 30 kg/m2, or current interfering medications are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, probiotics could offer a low-cost, well-tolerated approach to improve sperm quality and potentially increase chances of natural conception for some men.
How similar studies have performed: Small early studies and preliminary reports suggest probiotics may improve motility and reduce DNA fragmentation in some men, but clinical evidence in larger human trials remains limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males aged 20 to 45 years * Diagnosis of unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia * Sperm concentration \< 5 x 10\^6/mL * Sperm total motility \< 40% * Sperm morphology (Kruger strict criteria) \< 4% Exclusion Criteria: * 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
Where this trial is running
New Taipei City
- MacKay Memorial Hospital — New Taipei City, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Sheng-Hsiang Li, PhD
- Email: lsh@mmh.org.tw
- Phone: 886-2-28094661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Male Infertility, Oligozoospermia, Asthenozoospermia, Teratozoospermia, Oligoasthenoteratozoospermia, Probiotics, Sperm Motility, Sperm DNA