The Association of Gut Microbiota and Spermatogenic Dysfunction (NCT05628987) | Clinical Trial Compass
RecruitingNot Applicable
The Association of Gut Microbiota and Spermatogenic Dysfunction
China306 participantsStarted 2023-02-20
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexMALE
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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 Cro…