Regional variation limits applications of healthy gut microbiome reference ranges and disease models.
Yan He, Wei Wu, Hui-Min Zheng...
https://pubmed.ncbi.nlm.nih.gov/30150716Actively Recruiting
Age: 18Years - 45Years
MALE
Healthy Volunteers
ID05628987
The Association of Gut Microbiota and Spermatogenic Dysfunction
Led by Zhujiang Hospital · Updated on 2024-07-24
306
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zhujiang Hospital
Lead Sponsor
N
National Natural Science Foundation of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore the relationship between gut microbiota and sperm quality in men, focusing on conditions like azoospermia, oligozoospermia, asthenozoospermia, and teratozoospermia. Infertility affects many couples worldwide, with approximately half of cases linked to male factors. The study investigates how the gut microbiome and metabolomics relate to sperm health using detailed semen analysis based on World Health Organization guidelines. Participants will undergo stool, blood, and urine sample collection after completing two semen analyses following an abstinence period of 2-7 days. The study groups include men with different sperm abnormalities and a control group with normal semen results. Researchers will analyze microbiome and metabolomics data to compare across these groups. During the study, participants will provide samples and complete questionnaires covering lifestyle factors such as smoking, diet, physical activity, and stress. Researchers will monitor various measures including sperm concentration, motility, morphology, and related health indicators. The primary outcomes focus on microbiome and metabolomics data, with secondary assessments on lifestyle and health factors. Participation duration aligns with completing baseline assessments.
CONDITIONS
Brief Title
The Association of Gut Microbiota and Spermatogenic Dysfunction
Who Can Participate
Age: 18Years - 45Years
MALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 45 years
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m²
- Two abnormal semen analyses after 2-7 days abstinence showing azoospermia (absence of spermatozoa), oligozoospermia (total sperm number <3910^6 per ejaculate or concentration <1510^6 per ml), asthenozoospermia (progressive motility <32%), or teratozoospermia (morphologically normal spermatozoa <4%)
- Willing to provide stool, urine, and blood samples
- Able to complete questionnaires on lifestyle factors such as smoking, environment, physical activity, diet, and stress
You will not qualify if you...
- Age below 18 or above 45 years
- Use of Zocanidin, Vitamin E, antibiotics, clyster, gastrointestinal endoscope, or other drugs affecting semen quality or gut microbiota in the past 30 days
- History of high alcohol consumption in the past week or regular drinking in the past month
- Known genetic causes of male infertility, including chromosomal or gene disorders
- History of male reproductive system damage, surgery, tumor, or infection
- History of Crohn's disease, ulcerative colitis, acute gastrointestinal disease, renal failure, liver cirrhosis, hypoplasia, X-ray exposure, or related diseases
- History of intestinal gastrointestinal surgery excluding appendix surgery
- History of psychoses or mental conditions causing cognitive impairment that would prevent participation, including informed consent process
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants complete basic semen analysis and provide stool, blood, and urine samples to assess sperm quality and gut microbiome.
1 visit (in-person)
Long-term Monitoring
Duration - Up to study completion
Participants complete questionnaires on lifestyle factors including smoking, physical activity, diet, and stress to support observational data collection.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
Guangdong Provincial Fertility Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
2
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
3
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, China, 510280
Actively Recruiting
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Research Team
S
Shuo Wang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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Published Research Related To This Trial
Potential Pathogenic Bacteria in Seminal Microbiota of Patients with Different Types of Dysspermatism.
Huijun Yang, Jiaming Zhang, Zhiwei Xue...
https://pubmed.ncbi.nlm.nih.gov/32327694Impairment of spermatogenesis and sperm motility by the high-fat diet-induced dysbiosis of gut microbes.
Ning Ding, Xin Zhang, Xue Di Zhang...
https://pubmed.ncbi.nlm.nih.gov/31900292Intestinal microbiota defines the GUT-TESTIS axis.
Emmanuelle Martinot, Laura Thirouard, Hélène Holota...
https://pubmed.ncbi.nlm.nih.gov/33985968