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Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia

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ClinicalTrials.gov Identifier: NCT03634644
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bing Yao, Jinling Hospital, China

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 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.


Condition or disease Intervention/treatment Phase
Male Infertility Due to Hypospermatogenesis Drug: Omega 3 fatty acid Drug: Placebo oral capsule Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : March 17, 2019
Estimated Study Completion Date : October 28, 2019


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 Name: 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




Primary Outcome Measures :
  1. sperm concentration [ Time Frame: 40 days ]
    sperm concentration


Secondary Outcome Measures :
  1. progressive ratio [ Time Frame: 40 days ]
    progressive sperm concentration/total sperm concentration


Other Outcome Measures:
  1. DNA fragmentation index [ Time Frame: 40 days ]
    DNA fragmentation index

  2. gut microbiota composition [ Time Frame: 40 days ]
    variation of gut microbiota composition collecting from patients' fecal sample



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634644


Contacts
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Contact: Bing Yao 86-25-80860174 yaobing@nju.edu.cn

Locations
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China, Jiangsu
Center for Reproductive Medicine, Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Bing Yao, MD    86-25-80860174    yaobing@nju.edu.cn   
Sponsors and Collaborators
Jinling Hospital, China

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Responsible Party: Bing Yao, Director of Center for Reproductive Medicine, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03634644     History of Changes
Other Study ID Numbers: Omeag-3PUFA for OAT
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bing Yao, Jinling Hospital, China:
male infertility
oligoasthenoteratospermia

Additional relevant MeSH terms:
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Infertility
Infertility, Male
Oligospermia
Genital Diseases, Male
Genital Diseases, Female