The Association of Gut Microbiota and Spermatogenic Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-45
SponsorZhujiang Hospital
About this trial
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
Qualifiers
Aged 18 to 45 years, males
Body Mass Index (BMI):18.5-29.9 kg/m²
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- no intervention
Treatment groups
306 Participants
are divided into 5 treatment groupsSponsors and collaborators
Zhujiang Hospital
Lead sponsor
National Natural Science Foundation of China
Collaborator
Source ClinicalTrials.gov