The Association of Gut Microbiota and Spermatogenic Dysfunction
NCT ID: NCT05628987
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
306 participants
OBSERVATIONAL
2023-02-20
2025-06-30
Brief Summary
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Detailed Description
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The primary objective of the study is to determine the links between the gut microbiome and sperm quality utilizing microbiome and metabolomics. Stool, blood, and urine will be collected when a patient completes basic semen analysis and informed consent is signed. Microbiome and metabolomics will be compared among aspermia, oligozoospermia, asthenozoospermia, teratozoospermia, and normal individuals.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Azoospermia
After an abstinence period of 2-7 days, two basic semen analysis, the absence of spermatozoa
no intervention
Observational studies, no intervention
Oligozoospermia
After an abstinence period of 2-7 days, the total sperm number \<39\*10\^6 per ejaculate or the sperm concentration \< 15 \* 10\^6 per ml
no intervention
Observational studies, no intervention
Asthenozoospermia
After an abstinence period of 2-7 days, the progressive motility (PR) \< 32%
no intervention
Observational studies, no intervention
Teratozoospermia
After an abstinence period of 2-7 days, the percentage of morphologically normal spermatozoa \<4%
no intervention
Observational studies, no intervention
Control
After an abstinence period of 2-7 days, the basic semen analysis is normal.
no intervention
Observational studies, no intervention
Interventions
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no intervention
Observational studies, no intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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National Natural Science Foundation of China
OTHER_GOV
Zhujiang Hospital
OTHER
Responsible Party
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Hongwei Zhou
Professor
Principal Investigators
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Hongwei Zhou
Role: STUDY_CHAIR
Southern Medical University, China
Locations
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Guangdong Provincial Fertility Hospital
Guangzhou, Guangdong, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Tao Jing
Role: primary
References
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He Y, Wu W, Zheng HM, Li P, McDonald D, Sheng HF, Chen MX, Chen ZH, Ji GY, Zheng ZD, Mujagond P, Chen XJ, Rong ZH, Chen P, Lyu LY, Wang X, Wu CB, Yu N, Xu YJ, Yin J, Raes J, Knight R, Ma WJ, Zhou HW. Regional variation limits applications of healthy gut microbiome reference ranges and disease models. Nat Med. 2018 Oct;24(10):1532-1535. doi: 10.1038/s41591-018-0164-x. Epub 2018 Aug 27.
Yang H, Zhang J, Xue Z, Zhao C, Lei L, Wen Y, Dong Y, Yang J, Zhang L. Potential Pathogenic Bacteria in Seminal Microbiota of Patients with Different Types of Dysspermatism. Sci Rep. 2020 Apr 23;10(1):6876. doi: 10.1038/s41598-020-63787-x.
Ding N, Zhang X, Zhang XD, Jing J, Liu SS, Mu YP, Peng LL, Yan YJ, Xiao GM, Bi XY, Chen H, Li FH, Yao B, Zhao AZ. Impairment of spermatogenesis and sperm motility by the high-fat diet-induced dysbiosis of gut microbes. Gut. 2020 Sep;69(9):1608-1619. doi: 10.1136/gutjnl-2019-319127. Epub 2020 Jan 2.
Martinot E, Thirouard L, Holota H, Monrose M, Garcia M, Beaudoin C, Volle DH. Intestinal microbiota defines the GUT-TESTIS axis. Gut. 2022 Apr;71(4):844-845. doi: 10.1136/gutjnl-2021-324690. Epub 2021 May 13. No abstract available.
Other Identifiers
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Zhujiangjj-03
Identifier Type: -
Identifier Source: org_study_id
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