Infertility, MaleNCT05628987
The Association of Gut Microbiota and Spermatogenic Dysfunction
An observational study of Infertility, Male and Azoospermia, run by Zhujiang Hospital at 3 sites in China.
Trial summary
This is a multicenter, case-control study that aims to investigate the relationship between microbiota and sperm quality via stool, blood, and urine microbiome, metabolomics, and collected clinical metadata. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male, Azoospermia, Oligozoospermia
- How many people
- 306 participants
- Where
- 3 sitesChina
- Study dates
- 20 Feb 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers and patients will be recruited from the outpatient clinics of the Department of Andrology, Reproduction in our participant hospitals. Patients are from licensed doctor of the clinical research center. The age of healthy volunteers and patients in the same hospital will be matched.
Who may be able to join
- Aged 18 to 45 years, males
- Body Mass Index (BMI):18.5-29.9 kg/m^2
- After an abstinence period of 2-7 days, two abnormal semen analysis, the absence of spermatozoa from both replicates will be included in the azoospermia group, the total sperm number (<39*10^6 per ejaculate) or the sperm concentration ( < 15 * 10^6 per ml) will be oligozoospermia group, the progressive motility (PR) (< 32%) will be asthenozoospermia group; the percentage of morphologically normal spermatozoa (<4%) will be teratozoospermia group
- Willing to provide feces, urine, blood samples, able to complete study questionnaires aimed at lifestyle factors (cigarette smoking, high temperature environment and others ) and other data collection instruments (e.g. physical activity, food frequency questionnaire, stress and others)
Who cannot join
- Age < 18 or > 45 years
- History of Zocanidin, Vitamin E, antibiotics, clyster, gastrointestinal endoscope in the past 30 days, or other drugs known to interact with semen quality or gut microbiota, history of high alcohol consumption (liquor over 200 ml, beer over 1000 ml) in the past 7 days or drinking every week in the past month
- A known genetic cause of male factor spermatogenesis dysfunction, including chromosomal or gene disorders (e.g. Y chromosome deletions, CFTR mutation)
- History of male reproductive system (e.g. testis, epididymis, seminiferous duct and others) damage, surgery, tumor or infection
- History of Crohn's disease, ulcerative colitis, acute gastrointestinal disease, renal failure, liver cirrhosis, hypoplasia, X-rays exposure and other diseases related to spermatogenic dysfunction, history of intestinal gastrointestinal surgery (exclude appendix surgery)
- History of psychoses or other mental conditions that would result in cognitive impairment and inability to participate in any part of this study including the informed consent process
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
Guangdong Provincial Fertility Hospital
Guangzhou, Guangdong, 510000
Xinzong Zhang, zhangxz0123@163.com
- Not yet recruiting
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510000
Tao Jing, 13570464923 ext. +86
- Recruiting
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, 510280
Shuo Wang, 13265068619 ext. +86, mywanuo@163.com
About this study
This is a multicenter, case-control study that aims to investigate the relationship between microbiota and sperm quality via stool, blood, and urine microbiome, metabolomics, and collected clinical metadata. The results of the spermatogenic dysfunction, including aspermia, oligozoospermia, asthenozoospermia, and teratozoospermia, will be compared to normal basic semen analysis utilizing the World Health Organization (WHO) semen analysis procedure 5th edition.
Read the detailed description
Infertility is a global issue that affects as much as 10%-15% of couples. Approximately half of infertility can be attributed to men. Recently, a worldwide accelerated decline in sperm counts was reported. And the gut microbiome modulates many physiological functions and diseases, including host immunity, metabolic diseases, neuropsychiatric disorders, and so on. Recent publications demonstrate the links between intestinal microbiota and sperm production in fat animals and a few patients. And systemic clinical research would be necessary to explore the human microbiota and males with fertility disorders.
The primary objective of the study is to determine the links between the gut microbiome and sperm quality utilizing microbiome and metabolomics. Stool, blood, and urine will be collected when a patient completes basic semen analysis and informed consent is signed. Microbiome and metabolomics will be compared among aspermia, oligozoospermia, asthenozoospermia, teratozoospermia, and normal individuals.
- Being tested
- no intervention
- Keywords
- Microbiota, Infertility, Male, Sperm
- Medical subject headings
- Infertility, Male, Azoospermia, Oligospermia, Asthenozoospermia, Teratozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Observational studies, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Azoospermia | After an abstinence period of 2-7 days, two basic semen analysis, the absence of spermatozoa Receives: Other: no intervention | |
| Oligozoospermia | After an abstinence period of 2-7 days, the total sperm number <39*10^6 per ejaculate or the sperm concentration < 15 * 10^6 per ml Receives: Other: no intervention | |
| Asthenozoospermia | After an abstinence period of 2-7 days, the progressive motility (PR) < 32% Receives: Other: no intervention | |
| Teratozoospermia | After an abstinence period of 2-7 days, the percentage of morphologically normal spermatozoa <4% Receives: Other: no intervention | |
| Control | After an abstinence period of 2-7 days, the basic semen analysis is normal. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome
The microbial composition of the stool samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis and metagenomics. Comparison of microbial abundance and diversity of healthy volunteers and patients with spermatogenic dysfunction.
Measured: Baseline
Metabolomics
Metabolomics is the large-scale study of small molecules, such as fatty acids, bile acids, lipid mediators and others. Comparison of metabolites of healthy volunteers and patients with spermatogenic dysfunction.
Measured: Baseline
Secondary outcomes (17)
Physical activity time
Analyzing physical activity (hours/week) of different groups. The questionnaire about Physical Activity Time, "Over the past 30 days, on average how many hours per week did you usually spend on physical activity?"
Measured: Baseline
Daily sitting time
Analyzing daily sitting time (hours) of different groups. The questionnaire about Daily Sitting Time, "Over the past 7 days, on average how many hours did you usually spend sitting on a typical day?"
Measured: Baseline
Eating habits
Analyzing eating habits (vegetarian or meat lover) of different groups.
Measured: Baseline
Sleeping time
Analyzing daily sleeping time (hours) of different groups. The questionnaire about Sleeping Time, "Over the past 7 days, on average how many hours did you usually sleep per day?"
Measured: Baseline
Education level
Analyzing education level (highest grade or level of school) of different groups. The questionnaire about Education Level, "What is the highest grade or level of school you have completed or the highest degree you have received? The response categories are: less than 9th grade education, 10-12th grade education (includes no diploma), some college or associates (AA) degree, and college graduate or higher."
Measured: Baseline
Family income (CNY)
Analyzing annual family income (CNY) of different groups. The questionnaire about Family Income, "How much is annual family income (CNY)?"
Measured: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Analyzing Patient Health Questionnaire-9 (PHQ-9) scores of different groups. The Patient Health Questionnaire 9 (PHQ-9) is one of the tools used to screen for the presence and severity of depression. Each response category of 'not at all', 'several days', 'more than half the days' and 'nearly every day' is assigned a score of 0, 1, 2 and 3 respectively. The total score is calculated by adding together the scores for the 9 questions. The final scores of 0-4, 5-9, 10-14, 15-19, 20-27 are the ranges for none, mild, moderate, moderately severe and severe, respectively.
Measured: Baseline
Years of smoking
Analyzing years of smoking of different groups. The questionnaire about Years of Smoking, "For about how many years have you smoked? 0 means non-smoker"
Measured: Baseline
Number of cigarettes smoked
Analyzing number of cigarettes smoked of different groups. The questionnaire about Number of Cigarettes Smoked, "During the past 30 days, on average how many cigarettes did you smoke per day? non-smoker choose 0"
Measured: Baseline
History of drinking in the past one month
Analyzing history of drinking of different groups in the past one month. "Considering all types of alcoholic beverages, during the past one month, do you have at least 1 drink of any kind of alcohol per week, not counting small tastes or sips? By a drink, I mean 500 ml beer, 50 ml liquor, or 500ml other type of alcoholic beverage."
Measured: Baseline
History of drinking in the past 7 days
Analyzing history of drinking of different groups in the past 7 days. "Considering all types of alcoholic beverages, during the past 4 weeks, do you have at least 1 drink of any kind of alcohol, not counting small tastes or sips? By a drink, I mean 1000 ml beer, 200 ml liquor, or 1000ml other type of alcoholic beverage.""Considering all types of alcoholic beverages, during the past one month, do you have at least 1 drink of any kind of alcohol per week, not counting small tastes or sips? By a drink, I mean 500 ml beer, 50 ml liquor, or 500ml other type of alcoholic beverage."
Measured: Baseline
Body Mass Index (BMI)
To analyze Body Mass Index (kg/m^2) of different groups, height(cm) and weight(kg) will be measured.
Measured: Baseline
Waistline
Analyzing waistline (cm) of different groups.
Measured: Baseline
Spermatic concentration
To analyze spermatic concentration (10^6 per ml). According to the World Health Organization (WHO) semen analysis procedure 5th edition, spermatic concentration will be measured.
Measured: Baseline
Total sperm count
To analyze total sperm count (10^6 per ejaculate). According to the World Health Organization (WHO) semen analysis procedure 5th edition, total sperm count will be measured.
Measured: Baseline
Spermatic progressive motility
To analyze spermatic progressive motility (%). According to the World Health Organization (WHO) semen analysis procedure 5th edition, progressive motility will be measured.
Measured: Baseline
Percentage of normal morphology of sperm
To analyze percentage of normal morphology of sperm (%). According to the World Health Organization (WHO) semen analysis procedure 5th edition, percentage of normal morphology of sperm will be measured.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start20 Feb 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Hongwei Zhou, Zhujiang Hospital
- Investigators
- Hongwei Zhou, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628987
- Sponsor's protocol ID
- Zhujiangjj-03
- Status last verified
- Jul 2024
- First submitted
- 17 Nov 2022
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He Y, Wu W, Zheng HM, Li P, McDonald D, Sheng HF, Chen MX, Chen ZH, Ji GY, Zheng ZD, Mujagond P, Chen XJ, Rong ZH, Chen P, Lyu LY, Wang X, Wu CB, Yu N, Xu YJ, Yin J, Raes J, Knight R, Ma WJ, Zhou HW. Regional variation limits applications of healthy gut microbiome reference ranges and disease models. Nat Med. 2018 Oct;24(10):1532-1535. doi: 10.1038/s41591-018-0164-x. Epub 2018 Aug 27.
PubMed 30150716Yang H, Zhang J, Xue Z, Zhao C, Lei L, Wen Y, Dong Y, Yang J, Zhang L. Potential Pathogenic Bacteria in Seminal Microbiota of Patients with Different Types of Dysspermatism. Sci Rep. 2020 Apr 23;10(1):6876. doi: 10.1038/s41598-020-63787-x.
PubMed 32327694Ding N, Zhang X, Zhang XD, Jing J, Liu SS, Mu YP, Peng LL, Yan YJ, Xiao GM, Bi XY, Chen H, Li FH, Yao B, Zhao AZ. Impairment of spermatogenesis and sperm motility by the high-fat diet-induced dysbiosis of gut microbes. Gut. 2020 Sep;69(9):1608-1619. doi: 10.1136/gutjnl-2019-319127. Epub 2020 Jan 2.
PubMed 31900292Martinot E, Thirouard L, Holota H, Monrose M, Garcia M, Beaudoin C, Volle DH. Intestinal microbiota defines the GUT-TESTIS axis. Gut. 2022 Apr;71(4):844-845. doi: 10.1136/gutjnl-2021-324690. Epub 2021 May 13. No abstract available.
PubMed 33985968
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Gut Microbiota and Spermatogenic Dysfunction
- ClinicalTrials.gov ID
- NCT05628987
- Acronym / sponsor ID
- Zhujiangjj-03
- Keywords
- Microbiota, Infertility, Male, Sperm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 29 Nov 2022 (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 is a multicenter, case-control study that aims to investigate the relationship between microbiota and sperm quality via stool, blood, and urine microbiome, metabolomics, and collected clinical metadata. The results of the spermatogenic dysfunction, including aspermia, oligozoospermia, asthenozoospermia, and teratozoospermia, will be compared to normal basic semen analysis utilizing the World Health Organization (WHO) semen analysis procedure 5th edition.
Detailed description
Infertility is a global issue that affects as much as 10%-15% of couples. Approximately half of infertility can be attributed to men. Recently, a worldwide accelerated decline in sperm counts was reported. And the gut microbiome modulates many physiological functions and diseases, including host immunity, metabolic diseases, neuropsychiatric disorders, and so on. Recent publications demonstrate the links between intestinal microbiota and sperm production in fat animals and a few patients. And systemic clinical research would be necessary to explore the human microbiota and males with fertility disorders.
The primary objective of the study is to determine the links between the gut microbiome and sperm quality utilizing microbiome and metabolomics. Stool, blood, and urine will be collected when a patient completes basic semen analysis and informed consent is signed. Microbiome and metabolomics will be compared among aspermia, oligozoospermia, asthenozoospermia, teratozoospermia, and normal individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Azoospermia | – | Other: no interventionAfter an abstinence period of 2-7 days, two basic semen analysis, the absence of spermatozoa |
| Oligozoospermia | – | Other: no interventionAfter an abstinence period of 2-7 days, the total sperm number <39*10^6 per ejaculate or the sperm concentration < 15 * 10^6 per ml |
| Asthenozoospermia | – | Other: no interventionAfter an abstinence period of 2-7 days, the progressive motility (PR) < 32% |
| Teratozoospermia | – | Other: no interventionAfter an abstinence period of 2-7 days, the percentage of morphologically normal spermatozoa <4% |
| Control | – | Other: no interventionAfter an abstinence period of 2-7 days, the basic semen analysis is normal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers and patients will be recruited from the outpatient clinics of the Department of Andrology, Reproduction in our participant hospitals. Patients are from licensed doctor of the clinical research center. The age of healthy volunteers and patients in the same hospital will be matched.
Key inclusion criteria (4 listed)
- Aged 18 to 45 years, males
- Body Mass Index (BMI):18.5-29.9 kg/m^2
- After an abstinence period of 2-7 days, two abnormal semen analysis, the absence of spermatozoa from both replicates will be included in the azoospermia group, the total sperm number (<39*10^6 per ejaculate) or the sperm concentration ( < 15 * 10^6 per ml) will be oligozoospermia group, the progressive motility (PR) (< 32%) will be asthenozoospermia group; the percentage of morphologically normal spermatozoa (<4%) will be teratozoospermia group
- Willing to provide feces, urine, blood samples, able to complete study questionnaires aimed at lifestyle factors (cigarette smoking, high temperature environment and others ) and other data collection instruments (e.g. physical activity, food frequency questionnaire, stress and others)
Key exclusion criteria (6 listed)
- Age < 18 or > 45 years
- History of Zocanidin, Vitamin E, antibiotics, clyster, gastrointestinal endoscope in the past 30 days, or other drugs known to interact with semen quality or gut microbiota, history of high alcohol consumption (liquor over 200 ml, beer over 1000 ml) in the past 7 days or drinking every week in the past month
- A known genetic cause of male factor spermatogenesis dysfunction, including chromosomal or gene disorders (e.g. Y chromosome deletions, CFTR mutation)
- History of male reproductive system (e.g. testis, epididymis, seminiferous duct and others) damage, surgery, tumor or infection
- History of Crohn's disease, ulcerative colitis, acute gastrointestinal disease, renal failure, liver cirrhosis, hypoplasia, X-rays exposure and other diseases related to spermatogenic dysfunction, history of intestinal gastrointestinal surgery (exclude appendix surgery)
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 |
|---|---|---|
| no interventionObservational studies, no intervention | Other | Asthenozoospermia, Azoospermia, Control, Oligozoospermia, Teratozoospermia |
Primary outcome
Microbiome
Time frame: Baseline
The microbial composition of the stool samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis and metagenomics. Comparison of microbial abundance and diversity of healthy volunteers and patients with spermatogenic dysfunction.
Metabolomics
Time frame: Baseline
Metabolomics is the large-scale study of small molecules, such as fatty acids, bile acids, lipid mediators and others. Comparison of metabolites of healthy volunteers and patients with spermatogenic dysfunction.
17 secondary outcomes
Physical activity time
Time frame: Baseline
Daily sitting time
Time frame: Baseline
Eating habits
Time frame: Baseline
Sleeping time
Time frame: Baseline
Education level
Time frame: Baseline
Family income (CNY)
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Years of smoking
Time frame: Baseline
Number of cigarettes smoked
Time frame: Baseline
History of drinking in the past one month
Time frame: Baseline
History of drinking in the past 7 days
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Waistline
Time frame: Baseline
Spermatic concentration
Time frame: Baseline
Total sperm count
Time frame: Baseline
Spermatic progressive motility
Time frame: Baseline
Percentage of normal morphology of sperm
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 30150716He Y, Wu W, Zheng HM, Li P, McDonald D, Sheng HF, Chen MX, Chen ZH, Ji GY, Zheng ZD, Mujagond P, Chen XJ, Rong ZH, Chen P, Lyu LY, Wang X, Wu CB, Yu N, Xu YJ, Yin J, Raes J, Knight R, Ma WJ, Zhou HW. Regional variation limits applications of healthy gut microbiome reference ranges and disease models. Nat Med. 2018 Oct;24(10):1532-1535. doi: 10.1038/s41591-018-0164-x. Epub 2018 Aug 27.
- Background: PubMed 32327694Yang H, Zhang J, Xue Z, Zhao C, Lei L, Wen Y, Dong Y, Yang J, Zhang L. Potential Pathogenic Bacteria in Seminal Microbiota of Patients with Different Types of Dysspermatism. Sci Rep. 2020 Apr 23;10(1):6876. doi: 10.1038/s41598-020-63787-x.
- Background: PubMed 31900292Ding N, Zhang X, Zhang XD, Jing J, Liu SS, Mu YP, Peng LL, Yan YJ, Xiao GM, Bi XY, Chen H, Li FH, Yao B, Zhao AZ. Impairment of spermatogenesis and sperm motility by the high-fat diet-induced dysbiosis of gut microbes. Gut. 2020 Sep;69(9):1608-1619. doi: 10.1136/gutjnl-2019-319127. Epub 2020 Jan 2.
- Background: PubMed 33985968Martinot E, Thirouard L, Holota H, Monrose M, Garcia M, Beaudoin C, Volle DH. Intestinal microbiota defines the GUT-TESTIS axis. Gut. 2022 Apr;71(4):844-845. doi: 10.1136/gutjnl-2021-324690. Epub 2021 May 13. No abstract available.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hongwei Zhou study chair
Southern Medical University, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Male and Azoospermia, run by Zhujiang Hospital at 3 sites in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuo Wang (13265068619 ext. +86, mywanuo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628987, which also lists 4 linked publications.
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 24 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.