The Association of Gut Microbiota and Spermatogenic Dysfunction

NCT05628987 | Recruiting

• 1 other identifier: Zhujiangjj-03
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 3

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.

Conditions

Infertility, Male; Azoospermia; Oligozoospermia; Asthenozoospermia; Teratozoospermia

Keywords

Microbiota; Infertility, Male; Sperm

Outcome Measures

Primary Outcomes (2)

• Microbiome

  The microbial composition of the stool samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis and metagenomics. Comparison of microbial abundance and diversity of healthy volunteers and patients with spermatogenic dysfunction.

  Baseline

• Metabolomics

  Metabolomics is the large-scale study of small molecules, such as fatty acids, bile acids, lipid mediators and others. Comparison of metabolites of healthy volunteers and patients with spermatogenic dysfunction.

  Baseline

Secondary Outcomes (17)

• Physical activity time

  Baseline

• Daily sitting time

  Baseline

• Eating habits

  Baseline

• Sleeping time

  Baseline

• Education level

  Baseline

Study Arms (5)

Azoospermia

After an abstinence period of 2-7 days, two basic semen analysis, the absence of spermatozoa

Other: 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

Other: no intervention

Asthenozoospermia

After an abstinence period of 2-7 days, the progressive motility (PR) \< 32%

Other: no intervention

Teratozoospermia

After an abstinence period of 2-7 days, the percentage of morphologically normal spermatozoa \<4%

Other: no intervention

Control

After an abstinence period of 2-7 days, the basic semen analysis is normal.

Other: no intervention

Interventions

no intervention OTHER

Observational studies, no intervention

Asthenozoospermia; Azoospermia; Control; Oligozoospermia; Teratozoospermia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients will be recruited from the outpatient clinics of the Department of Andrology, Reproduction in our participant hospitals. Patients are from licensed doctor of the clinical research center. The age of healthy volunteers and patients in the same hospital will be matched.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (3)

Guangdong Provincial Fertility Hospital

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, 510280, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 30150716 BACKGROUND

• 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.

  PMID: 32327694 BACKGROUND

• 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.

  PMID: 31900292 BACKGROUND

• 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.

  PMID: 33985968 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Feces, urine, blood

MeSH Terms

Conditions

Infertility, Male; Azoospermia; Oligospermia; Asthenozoospermia; Teratozoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Hongwei Zhou

  Southern Medical University, China

  STUDY CHAIR

Central Study Contacts

Shuo Wang

CONTACT

13265068619; mywanuo@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: February 20, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)