The Association of Gut Microbiota and Spermatogenic Dysfunction
Launched by ZHUJIANG HOSPITAL · Nov 17, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how the bacteria in our gut might affect male fertility, specifically issues related to sperm quality. Researchers will collect samples of stool, blood, and urine from male participants to study the relationship between these microbiota and different types of sperm problems, such as having no sperm (azoospermia), low sperm count (oligozoospermia), poor sperm movement (asthenozoospermia), or abnormal sperm shape (teratozoospermia). The results will be compared to those of men with normal sperm quality using standardized tests.
To be eligible for this study, participants need to be males aged 18 to 45 with a healthy weight. They should have had two sperm tests showing abnormalities after a short break from sexual activity. Participants must be willing to provide various samples and complete questionnaires about their lifestyle. Those with certain medical histories or conditions, such as severe alcohol use or specific genetic disorders, will not be able to join the study. If you or someone you know fits this description and is interested in helping understand male fertility better, this study could be a good opportunity.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 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)
- Exclusion Criteria:
- • 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
About Zhujiang Hospital
Zhujiang Hospital, affiliated with the Southern Medical University in Guangzhou, China, is a leading clinical research institution dedicated to advancing medical science and improving patient care through rigorous clinical trials. With a strong commitment to ethical standards and patient safety, the hospital boasts a multidisciplinary team of experienced researchers and healthcare professionals. Its state-of-the-art facilities enable the execution of innovative studies across various therapeutic areas, contributing valuable insights to the global medical community. Zhujiang Hospital aims to foster collaboration with academic institutions, pharmaceutical companies, and regulatory bodies to ensure the successful development of new therapies and enhance treatment options for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guanzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Patients applied
Trial Officials
Hongwei Zhou
Study Chair
Southern Medical University, China
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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