NCT07345455 Probiotics on Sperm Quality in Male Infertility Patients
| NCT ID | NCT07345455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mackay Memorial Hospital |
| Condition | Male Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-09-16 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-09-16 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07345455 clinical trial?
This trial is open to male participants only, aged 20 Years or older, up to 45 Years, studying Male Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07345455 currently recruiting?
Yes, NCT07345455 is actively recruiting participants. Contact the research team at lsh@mmh.org.tw for enrollment information.
Where is the NCT07345455 trial being conducted?
This trial is being conducted at New Taipei City, Taiwan.
Who is sponsoring the NCT07345455 clinical trial?
NCT07345455 is sponsored by Mackay Memorial Hospital. The trial plans to enroll 60 participants.