Probiotics on Sperm Quality in Male Infertility Patients

NCT ID: NCT07345455

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-16
• Study Completion Date: 2026-12-31

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.

Detailed Description

Content: Male infertility accounts for approximately 40% of infertility cases and is often characterized by abnormalities in sperm count, motility, and morphology. Factors such as oxidative stress, environmental hormones, and inflammation can lead to sperm DNA fragmentation and mitochondrial dysfunction, ultimately affecting fertilization potential. While probiotics are known to improve gut microbiome balance and regulate immunity, limited studies suggest they may also improve sperm motility and reduce DNA fragmentation in men with asthenozoospermia.

This pilot study employs a randomized, placebo-controlled design to evaluate the efficacy of probiotic supplementation in improving sperm quality. A total of 60 male participants with unexplained infertility (specifically oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia) will be recruited. Participants will be divided into two groups: an experimental group receiving probiotics and a control group receiving a placebo.

The study duration for each participant is approximately 100 days, with semen samples collected at three distinct time points:

1. Day 0 (Start Test): Baseline sample collection.

2. Day 60 (Mid Test): Interim sample collection.

3. Day 100 (Final Test): Post-intervention sample collection.

Semen analysis will be conducted using the following methodologies:

• Sperm Concentration and Motility: Analyzed using a Computer-Aided Sperm Assay (CASA) to measure parameters including total motility, progressive motility, VAP, VCL, VSL, Straightness, and Linearity.
• Sperm DNA Integrity: Assessed via the Sperm Chromatin Structure Assay (SCSA) using flow cytometry. Sperm are treated with acridine orange; red fluorescence indicates single-stranded DNA (fragmentation), while green fluorescence indicates double-stranded DNA. Results are expressed as the DNA Fragmentation Index (DFI).

Sperm Function (Acrosome Reaction): Evaluated using Peanut Agglutinin (PNA) staining. The assay determines the percentage of sperm capable of undergoing the acrosome reaction, a necessary step for fertilization.

Inclusion Criteria

• Gender: Male.
• Age: 20 to 45 years old.
• Diagnosis: Diagnosed with unexplained oligozoospermia, asthenozoospermia, or oligoasthenoteratozoospermia.
• Semen Parameters:

• Sperm concentration < 5×106/mL (Note: Source indicates "5x10/mL", contextually adjusted to standard unit for oligozoospermia).
• Sperm motility < 40%.
• Sperm morphology (Kruger strict criteria) < 4%. Exclusion Criteria

1. History of hormonal disorders or epididymo-orchitis.

2. Substance abuse, including drugs or excessive alcohol consumption.

3. Diabetes mellitus.

4. Kidney disease (defined as a doubling of creatinine levels or more).

5. Chronic liver disease.

6. Varicocele.

7. Current use of medications that interfere with hormones.

8. Occupational or environmental exposure to pesticides, heavy metals, or solvents.

9. Intake of antioxidant supplements within the past three months.

10. Body Mass Index (BMI) of 30 kg/m² or higher.

Conditions

Male Infertility; Oligozoospermia; Asthenozoospermia; Teratozoospermia; Oligoasthenoteratozoospermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: Probiotics Group

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

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

The subjects take 2 probiotic capsules after each meal daily.

Placebo Comparator: Control Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotics

The subjects take 2 probiotic capsules after each meal daily.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Grape King Bio Ltd.

INDUSTRY

Sponsor Role: collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MacKay Memorial Hospital

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Sheng-Hsiang Li, PhD

Role: CONTACT

lsh@mmh.org.tw

886-2-28094661 ext. 2357

Facility Contacts

Sheng-Hsiang Li, PhD

Role: primary

lsh@mmh.org.tw

886-2-28094661 ext. 2357

Other Identifiers

GP001

Identifier Type: -

Identifier Source: org_study_id