NCT05628987 The Association of Gut Microbiota and Spermatogenic Dysfunction
| NCT ID | NCT05628987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Infertility, Male |
| Study Type | OBSERVATIONAL |
| Enrollment | 306 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 306 participants in total. It began in 2023-02-20 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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
Contact & Investigator
Hongwei Zhou
STUDY CHAIR
Southern Medical University, China
Frequently Asked Questions
Who can join the NCT05628987 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 45 Years, studying Infertility, Male. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05628987 currently recruiting?
Yes, NCT05628987 is actively recruiting participants. Contact the research team at mywanuo@163.com for enrollment information.
Where is the NCT05628987 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guanzhou, China.
Who is sponsoring the NCT05628987 clinical trial?
NCT05628987 is sponsored by Zhujiang Hospital. The principal investigator is Hongwei Zhou at Southern Medical University, China. The trial plans to enroll 306 participants.