Probiotics on Sperm Quality in Male Infertility Patients

NCT07345455 | Recruiting

• 1 other identifier: GP001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility; Oligozoospermia; Asthenozoospermia; Teratozoospermia; Oligoasthenoteratozoospermia

Keywords

Probiotics; Sperm Motility; Sperm DNA; Sperm Function; Oligozoospermia; Asthenozoospermia

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Day 60, Day 100

Secondary Outcomes (2)

• Change From Baseline in Sperm DNA Fragmentation Index (DFI) Assessed by SCSA

  Day 60, Day 100

• Change From Baseline in Sperm Acrosome Reaction Rate Assessed by PNA Staining

  Day 60, Day 100

Study Arms (2)

Experimental: Probiotics Group

EXPERIMENTAL

The experimental group takes probiotics, two capsules a day, after meals.

Dietary Supplement: Probiotics

Placebo Comparator: Control Group

PLACEBO COMPARATOR

The control group is given the same dosage form without probiotics (placebo), two capsules a day, after meals.

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

The subjects take 2 probiotic capsules after each meal daily.

Experimental: Probiotics Group

Placebo DIETARY_SUPPLEMENT

The control group takes two placebo capsules (containing no probiotics) after meals daily.

Placebo Comparator: Control Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Grape King Bio Ltd.: collaborator

Study Sites (1)

MacKay Memorial Hospital

New Taipei City, 25160, Taiwan

RECRUITING

MeSH Terms

Conditions

Infertility, Male; Oligospermia; Asthenozoospermia; Teratozoospermia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Sheng-Hsiang Li, PhD

CONTACT

886-2-28094661; lsh@mmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The control group receives a placebo identical in dosage form and appearance to the probiotic supplement, to ensure masking of participants and investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project will collect 60 male infertility patients (mainly those with oligozoospermia and asthenozoospermia) for a period of two years and divide them into an experimental group and a control group. The experimental group was given probiotics, while the control group was given the same dosage form without probiotics (placebo).

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: January 15, 2026
• Study Start: September 16, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-01

Locations

TW (1)