Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia

• Sponsor: Jinling Hospital, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03634644
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase 1

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 Design

• Study Type: Interventional
• Anticipated 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: Nov 8, 2017
• Actual Primary Completion Date: Mar 17, 2019
• Anticipated Study Completion Date: Oct 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. sperm concentration [40 days]

   sperm concentration

Secondary Outcome Measures

1. progressive ratio [40 days]

   progressive sperm concentration/total sperm concentration

Other Outcome Measures

1. DNA fragmentation index [40 days]

   DNA fragmentation index

2. gut microbiota composition [40 days]

   variation of gut microbiota composition collecting from patients' fecal sample

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Reproductive Medicine, Jinling Hospital	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

• Jinling Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bing Yao, Director of Center for Reproductive Medicine, Jinling Hospital, China
• ClinicalTrials.gov Identifier: NCT03634644
• Other Study ID Numbers: Omeag-3PUFA for OAT
• First Posted: Aug 16, 2018
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bing Yao, Director of Center for Reproductive Medicine, Jinling Hospital, China: male infertility; oligoasthenoteratospermia
• Additional relevant MeSH terms: Infertility; Infertility, Male; Oligospermia

Study Results

No Results Posted as of Sep 16, 2021