Investigating the link between gut microbiota and male sperm quality
The Association of Gut Microbiota and Spermatogenic Dysfunction
This study is trying to see if the bacteria in the gut affect sperm quality in men who have fertility issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 306 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 3 sites (Guangzhou, Guangdong and 2 other locations) |
| Trial ID | NCT05628987 on ClinicalTrials.gov |
What this trial studies
This multicenter, case-control study aims to explore the relationship between gut microbiota and sperm quality in males experiencing various forms of spermatogenic dysfunction, including azoospermia, oligozoospermia, asthenozoospermia, and teratozoospermia. Participants aged 18 to 45 will provide stool, blood, and urine samples after undergoing semen analysis. The study will compare microbiome and metabolomic profiles between those with sperm quality issues and healthy individuals, utilizing the WHO semen analysis guidelines. The findings could enhance understanding of how gut health influences male fertility.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 to 45 with diagnosed spermatogenic dysfunction.
Not a fit: Patients outside the age range of 18 to 45 or those with recent gastrointestinal interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the treatment of male infertility by targeting gut microbiota.
How similar studies have performed: While some studies have suggested links between gut microbiota and sperm production, this approach is relatively novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong and 2 other locations
- Guangdong Provincial Fertility Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Guangdong Second Provincial General Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Zhujiang Hospital of Southern Medical University — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Shuo Wang
- Email: mywanuo@163.com
- Phone: 13265068619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.