Viewing Study NCT03634644



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Last Modification Date: 2024-10-26 @ 12:52 PM
Study NCT ID: NCT03634644
Status: UNKNOWN
Last Update Posted: 2021-09-16
First Post: 2018-08-12

Brief Title: Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia
Sponsor: Jinling Hospital China
Organization: Jinling Hospital China

Study Overview

Official Title: Omega-3 Polyunsaturated Fatty Acids for the Treatment of Patients With Idiopathic Oligoasthenoteratospermia A Double-blind Placebo-controlled and Randomized Exploratory Clinical Trial
Status: UNKNOWN
Status Verified Date: 2021-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Investigators have previously found that sperm quality was not related to obesity indicators such as body mass index bmi waist circumference waist-hip ratio girth ratio and serum lipid but seminal plasma lipids could notably affect the sperm concentration sperm progressive ratioPR sperm DNA fragmentation index DFI These results indicates that abnormal lipid metabolism in the male reproductive system may affect male fertility

It seems that the sperm fatty acid spectrum is associated with n-3 polyunsaturated fatty acids PUFA in dietary Docosahexaenoic Acid DHA and Eicosapentaenoic Acid EPA are the most common n-3 PUFA Only plasma DHAEPA may reflect the quantity of DHAEPA in adults Most research indicate that n-3 PUFA is the main polyunsaturated fatty acid in human sperm

It is well known that diets have great influence on the gut microbiota composition Many researches have delineated the cause and effect relationship between disturbed gut microbes and diseases such as irritable bowel syndrome obesity diabetes The disturbed gut microbiota ecosystem may also lead to the intestinal mucosal permeability increasing which may result in endotoxemia and a series of metabolic syndrome N-3 polyunsaturated fatty acids may play an important role in regulating metabolism and physiological functions in the body A clinical research found that both total n-3 PUFA and DHA serum levels were significantly correlated with microbiome alpha diversity Therefore investigators may try to figure out the influence of n-3 PUFA supplement on gut microbiota composition and whether the gut microbiota have influence on sperm parameters So investigators apply for your permission to collected the fecal samples from the participants which will be a meaningful work
Detailed Description: In the previous work investigators found high fat diet induced gut microbiota dysbiosis can lead to low sperm motility and sperm count and also recognised some microbes which may lead to the low sperm motility and sperm count It is obvious that gut microbiota can influence the sperm quality And the supplement of n-3 PUFA is significantly correlated with microbiome alpha diversity So investigators want to collected the fecal samples from the participants to ascertain whether the supplementation of n-3 PUFA can promote sperm parameters by improve gut microbiota ecosystem

The potential microbes planing to cultivate Prevotella spp bacteroides spp

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None