Probiotics on Sperm Quality in Male Infertility Patients
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Male Infertility, Oligozoospermia, Asthenozoospermia, Teratozoospermia, Oligoasthenoteratozoospermia
In brief
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.
Key facts
- Study ID
- NCT07345455
- Run by
- Mackay Memorial Hospital
- People needed
- 60
- Starts
- 2023-09-16
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-15
Who can join
Age: 20 and older, up to 45. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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 it is running
- MacKay Memorial Hospital — New Taipei City, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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