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临床试验/NCT03634644
NCT03634644Unknown1 期

Omega-3 Polyunsaturated Fatty Acids for the Treatment of Patients With Idiopathic Oligoasthenoteratospermia: A Double-blind, Placebo-controlled and Randomized Exploratory Clinical Trial

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
30
试验地点
1
主要终点
sperm concentration

研究概览

简要总结

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 ratio(PR), 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 DHA/EPA may reflect the quantity of DHA/EPA 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Clinical diagnosis of Oligoasthenoteratospermia.

排除标准

  • Leukocytospermia, prostatitis, genital trauma, testicular torsion, urinary tract infections, cryptorchidism, varicocele, diabetes, inguinal and genital surgery.
  • Y chromosome microdeletion and chromosomal karyotype abnormality.
  • Extreme oligospermia.
  • Hepatobiliary diseases, kidney failure.

研究组 & 干预措施

Omega-3 fatty acid capsule

Active Comparator

1g per capsule(EPA400mg,DHA320mg)

干预措施: Omega 3 fatty acid (Drug)

Placebo capsule

Placebo Comparator

The placebo capsule has same appearance and packing with the Omega-3 fatty acid capsule

干预措施: Placebo oral capsule (Drug)

结局指标

主要结局

sperm concentration

时间窗: 40 days

sperm concentration

次要结局

  • progressive ratio(40 days)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bing Yao

Director of Center for Reproductive Medicine

Jinling Hospital, China

研究点 (1)

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