Health TrialsbyHealthPanel

The Association of Gut Microbiota and Spermatogenic Dysfunction

ConditionsInfertility, MaleAzoospermiaOligozoospermiaAsthenozoospermiaTeratozoospermia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-45
SponsorZhujiang Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 45 years, males

Body Mass Index (BMI):18.5-29.9 kg/m²

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • no intervention

    Other intervention

    Observational studies, no intervention

Treatment groups

306 Participants
are divided into 5 treatment groups
Group A: Azoospermia1 intervention
Group B: Oligozoospermia1 intervention
Group C: Asthenozoospermia1 intervention
Group D: Teratozoospermia1 intervention
Group E: Control1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline

Secondary outcomes

1

Physical activity time

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
2

Daily sitting time

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
3

Eating habits

Analyzing eating habits (vegetarian or meat lover) of different groups.

Time frame
Baseline
4

Sleeping time

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhujiang Hospital

Lead sponsor

National Natural Science Foundation of China

Collaborator

Source ClinicalTrials.gov
Apply now