Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2022-10-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Male Infertility Due to Hypospermatogenesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3 fatty acid capsule

1g per capsule(EPA400mg，DHA320mg)

Group Type ACTIVE_COMPARATOR

Omega 3 fatty acid

Intervention Type DRUG

Omega 3 fatty acid,mainly composed of EPA and DHA.

Placebo capsule

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

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

mainly composed of corn oil

Interventions

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Omega 3 fatty acid

Omega 3 fatty acid,mainly composed of EPA and DHA.

Intervention Type DRUG

Placebo oral capsule

mainly composed of corn oil

Intervention Type DRUG

Other Intervention Names

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Placebo Capsule

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No