No intervention
OtherObservational studies, no intervention
NCT Number: NCT05628987
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.
Interested in participating?
Request Info18 year–45 year
Male
Observational
Guangdong Provincial Fertility Hospital, Guangzhou, Guangdong, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observational studies, no intervention
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
Analyzing physical activity (hours/week) of different groups. The questionnaire about Physical Activity Time, "Over the past 30 days, on average how many hours per week did you usually spend on physical activity?"
Time frame: Baseline
Analyzing daily sitting time (hours) of different groups. The questionnaire about Daily Sitting Time, "Over the past 7 days, on average how many hours did you usually spend sitting on a typical day?"
Time frame: Baseline
Analyzing eating habits (vegetarian or meat lover) of different groups.
Time frame: Baseline
Analyzing daily sleeping time (hours) of different groups. The questionnaire about Sleeping Time, "Over the past 7 days, on average how many hours did you usually sleep per day?"
Time frame: Baseline
Analyzing education level (highest grade or level of school) of different groups. The questionnaire about Education Level, "What is the highest grade or level of school you have completed or the highest degree you have received? The response categories are: less than 9th grade education, 10-12th grade education (includes no diploma), some college or associates (AA) degree, and college graduate or higher."
Time frame: Baseline
Analyzing annual family income (CNY) of different groups. The questionnaire about Family Income, "How much is annual family income (CNY)?"
Time frame: Baseline
Analyzing Patient Health Questionnaire-9 (PHQ-9) scores of different groups. The Patient Health Questionnaire 9 (PHQ-9) is one of the tools used to screen for the presence and severity of depression. Each response category of 'not at all', 'several days', 'more than half the days' and 'nearly every day' is assigned a score of 0, 1, 2 and 3 respectively. The total score is calculated by adding together the scores for the 9 questions. The final scores of 0-4, 5-9, 10-14, 15-19, 20-27 are the ranges for none, mild, moderate, moderately severe and severe, respectively.
Time frame: Baseline
Analyzing years of smoking of different groups. The questionnaire about Years of Smoking, "For about how many years have you smoked? 0 means non-smoker"
Time frame: Baseline
Analyzing number of cigarettes smoked of different groups. The questionnaire about Number of Cigarettes Smoked, "During the past 30 days, on average how many cigarettes did you smoke per day? non-smoker choose 0"
Time frame: Baseline
Analyzing history of drinking of different groups in the past one month. "Considering all types of alcoholic beverages, during the past one month, do you have at least 1 drink of any kind of alcohol per week, not counting small tastes or sips? By a drink, I mean 500 ml beer, 50 ml liquor, or 500ml other type of alcoholic beverage."
Time frame: Baseline
Analyzing history of drinking of different groups in the past 7 days. "Considering all types of alcoholic beverages, during the past 4 weeks, do you have at least 1 drink of any kind of alcohol, not counting small tastes or sips? By a drink, I mean 1000 ml beer, 200 ml liquor, or 1000ml other type of alcoholic beverage.""Considering all types of alcoholic beverages, during the past one month, do you have at least 1 drink of any kind of alcohol per week, not counting small tastes or sips? By a drink, I mean 500 ml beer, 50 ml liquor, or 500ml other type of alcoholic beverage."
Time frame: Baseline
To analyze Body Mass Index (kg/m^2) of different groups, height(cm) and weight(kg) will be measured.
Time frame: Baseline
Analyzing waistline (cm) of different groups.
Time frame: Baseline
To analyze spermatic concentration (10^6 per ml). According to the World Health Organization (WHO) semen analysis procedure 5th edition, spermatic concentration will be measured.
Time frame: Baseline
To analyze total sperm count (10^6 per ejaculate). According to the World Health Organization (WHO) semen analysis procedure 5th edition, total sperm count will be measured.
Time frame: Baseline
To analyze spermatic progressive motility (%). According to the World Health Organization (WHO) semen analysis procedure 5th edition, progressive motility will be measured.
Time frame: Baseline
To analyze percentage of normal morphology of sperm (%). According to the World Health Organization (WHO) semen analysis procedure 5th edition, percentage of normal morphology of sperm will be measured.
Contact information is provided by the study sponsor or research team.
Zhujiang Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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