Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Male Infertility Due to Hypospermatogenesis
• Intervention / Treatment: Drug: Omega 3 fatty acid; Drug: Placebo oral capsule

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bing Yao; Phone Number: 86-25-80860174; Email: yaobing@nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Center for Reproductive Medicine, Jinling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Clinical diagnosis of Oligoasthenoteratospermia.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Omega-3 fatty acid capsule; 1g per capsule(EPA400mg，DHA320mg)	Drug: Omega 3 fatty acid; Omega 3 fatty acid,mainly composed of EPA and DHA.; Other Names: Placebo Capsule
PLACEBO_COMPARATOR: Placebo capsule; The placebo capsule has same appearance and packing with the Omega-3 fatty acid capsule	Drug: Placebo oral capsule; mainly composed of corn oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sperm concentration	sperm concentration	40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progressive ratio	progressive sperm concentration/total sperm concentration	40 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
DNA fragmentation index	DNA fragmentation index	40 days
gut microbiota composition	variation of gut microbiota composition collecting from patients' fecal sample	40 days

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Publications and helpful links

General Publications

• Ding N, Zhang X, Zhang XD, Jing J, Liu SS, Mu YP, Peng LL, Yan YJ, Xiao GM, Bi XY, Chen H, Li FH, Yao B, Zhao AZ. Impairment of spermatogenesis and sperm motility by the high-fat diet-induced dysbiosis of gut microbes. Gut. 2020 Sep;69(9):1608-1619. doi: 10.1136/gutjnl-2019-319127. Epub 2020 Jan 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 8, 2017
• Primary Completion (ACTUAL): March 17, 2019
• Study Completion (ANTICIPATED): October 28, 2022

Study Registration Dates

• First Submitted: August 12, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (ACTUAL): August 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: male infertility; oligoasthenoteratospermia
• Additional Relevant MeSH Terms: Infertility; Infertility, Male; Oligospermia
• Other Study ID Numbers: Omeag-3PUFA for OAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No