Male InfertilityNCT07345455
Probiotics on Sperm Quality in Male Infertility Patients
A study testing Probiotics in people with Male Infertility and Oligozoospermia, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Male Infertility, Oligozoospermia, Asthenozoospermia
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
MacKay Memorial Hospital
New Taipei City, 25160
Sheng-Hsiang Li, PhD, 886-2-28094661 ext. 2357, lsh@mmh.org.tw
About this study
Official title: Effect of Probiotics on Sperm Quality in Male Infertility Patients
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.
Read more
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.
Read the 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:
- Day 0 (Start Test): Baseline sample collection.
- Day 60 (Mid Test): Interim sample collection.
- 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
- 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/m² or higher.
- Conditions
- Male Infertility, Oligozoospermia, Asthenozoospermia, Teratozoospermia, Oligoasthenoteratozoospermia
- Being tested
- Probiotics, Placebo
- Keywords
- Probiotics, Sperm Motility, Sperm DNA, Sperm Function, Oligozoospermia, Asthenozoospermia
- Medical subject headings
- Infertility, Male, Oligospermia, Asthenozoospermia, Teratozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
The subjects take 2 probiotic capsules after each meal daily.
PlaceboDietary supplement
The control group takes two placebo capsules (containing no probiotics) after meals daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Probiotics Group | Experimental | The experimental group takes probiotics, two capsules a day, after meals. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 60, Day 100
Secondary outcomes (2)
Change From Baseline in Sperm DNA Fragmentation Index (DFI) Assessed by SCSA
Sperm DNA integrity will be assessed using the Sperm Chromatin Structure Assay (SCSA) via flow cytometry. Sperm are stained with acridine orange. The result is expressed as the DNA Fragmentation Index (DFI), representing the ratio of red fluorescence (fragmented DNA) to total fluorescence (red + green). A lower DFI indicates better DNA integrity.
Measured: Day 60, Day 100
Change From Baseline in Sperm Acrosome Reaction Rate Assessed by PNA Staining
Sperm function will be evaluated by the acrosome reaction assay using peanut agglutinin (PNA) staining. The percentage of sperm that have undergone the acrosome reaction (indicated by specific staining patterns observed under a fluorescence microscope) will be calculated. This measures the sperm's physiological capability to fertilize an egg.
Measured: Day 60, Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start16 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345455
- Sponsor's protocol ID
- GP001
- Status last verified
- Jan 2025
- First submitted
- 7 May 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Sperm Quality in Male Infertility Patients
- ClinicalTrials.gov ID
- NCT07345455
- Acronym / sponsor ID
- GP001
- Conditions
- Male Infertility, Oligozoospermia, Asthenozoospermia, Teratozoospermia, Oligoasthenoteratozoospermia
- Keywords
- Probiotics, Sperm Motility, Sperm DNA, Sperm Function, Oligozoospermia, Asthenozoospermia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 16 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Day 0 (Start Test): Baseline sample collection.
- Day 60 (Mid Test): Interim sample collection.
- 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
- 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/m² or higher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental: Probiotics Group | Experimental | Dietary Supplement: ProbioticsThe experimental group takes probiotics, two capsules a day, after meals. |
| Placebo Comparator: Control Group | Placebo comparator | Dietary Supplement: PlaceboThe control group is given the same dosage form without probiotics (placebo), two capsules a day, after meals. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsThe subjects take 2 probiotic capsules after each meal daily. | Dietary supplement | Experimental: Probiotics Group |
| PlaceboThe control group takes two placebo capsules (containing no probiotics) after meals daily. | Dietary supplement | Placebo Comparator: Control Group |
Primary outcome
Change From Baseline in Sperm Concentration Assessed by Computer-Aided Sperm Analysis (CASA)
Time frame: Day 60, Day 100
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.
Change From Baseline in Total Sperm Motility Percentage Assessed by Computer-Aided Sperm Analysis (CASA)
Time frame: Day 60, Day 100
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.
Change From Baseline in Percentage of Normal Sperm Morphology Assessed by Computer-Aided Sperm Analysis (CASA)
Time frame: Day 60, Day 100
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.
2 secondary outcomes
Change From Baseline in Sperm DNA Fragmentation Index (DFI) Assessed by SCSA
Time frame: Day 60, Day 100
Change From Baseline in Sperm Acrosome Reaction Rate Assessed by PNA Staining
Time frame: Day 60, Day 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Male Infertility and Oligozoospermia, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Hsiang Li, PhD (886-2-28094661 ext. 2357, lsh@mmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Sperm Concentration Assessed by Computer-Aided Sperm Analysis (CASA) (time frame: Day 60, Day 100). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.