Trials / Recruiting
RecruitingNCT05628987
The Association of Gut Microbiota and Spermatogenic Dysfunction
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 306 (estimated)
- Sponsor
- Zhujiang Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Infertility is a global issue that affects as much as 10%-15% of couples. Approximately half of infertility can be attributed to men. Recently, a worldwide accelerated decline in sperm counts was reported. And the gut microbiome modulates many physiological functions and diseases, including host immunity, metabolic diseases, neuropsychiatric disorders, and so on. Recent publications demonstrate the links between intestinal microbiota and sperm production in fat animals and a few patients. And systemic clinical research would be necessary to explore the human microbiota and males with fertility disorders. 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | no intervention | Observational studies, no intervention |
Timeline
- Start date
- 2023-02-20
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
- First posted
- 2022-11-29
- Last updated
- 2024-07-24
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05628987. Inclusion in this directory is not an endorsement.