Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia
Primary Purpose
Male Infertility Due to Hypospermatogenesis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Omega 3 fatty acid
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility Due to Hypospermatogenesis focused on measuring male infertility, oligoasthenoteratospermia
Eligibility 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.
Sites / Locations
- Center for Reproductive Medicine, Jinling HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Omega-3 fatty acid capsule
Placebo capsule
Arm Description
1g per capsule(EPA400mg,DHA320mg)
The placebo capsule has same appearance and packing with the Omega-3 fatty acid capsule
Outcomes
Primary Outcome Measures
sperm concentration
sperm concentration
Secondary Outcome Measures
progressive ratio
progressive sperm concentration/total sperm concentration
Full Information
NCT ID
NCT03634644
First Posted
August 12, 2018
Last Updated
September 8, 2021
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT03634644
Brief Title
Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
March 17, 2019 (Actual)
Study Completion Date
October 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility Due to Hypospermatogenesis
Keywords
male infertility, oligoasthenoteratospermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 fatty acid capsule
Arm Type
Active Comparator
Arm Description
1g per capsule(EPA400mg,DHA320mg)
Arm Title
Placebo capsule
Arm Type
Placebo Comparator
Arm Description
The placebo capsule has same appearance and packing with the Omega-3 fatty acid capsule
Intervention Type
Drug
Intervention Name(s)
Omega 3 fatty acid
Other Intervention Name(s)
Placebo Capsule
Intervention Description
Omega 3 fatty acid,mainly composed of EPA and DHA.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
mainly composed of corn oil
Primary Outcome Measure Information:
Title
sperm concentration
Description
sperm concentration
Time Frame
40 days
Secondary Outcome Measure Information:
Title
progressive ratio
Description
progressive sperm concentration/total sperm concentration
Time Frame
40 days
Other Pre-specified Outcome Measures:
Title
DNA fragmentation index
Description
DNA fragmentation index
Time Frame
40 days
Title
gut microbiota composition
Description
variation of gut microbiota composition collecting from patients' fecal sample
Time Frame
40 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Yao
Phone
86-25-80860174
Email
yaobing@nju.edu.cn
Facility Information:
Facility Name
Center for Reproductive Medicine, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Yao, MD
Phone
86-25-80860174
Email
yaobing@nju.edu.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
31900292
Citation
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.
Results Reference
derived
Learn more about this trial
Omega-3 PUFA for Treatment of Patients With Idiopathic Oligoasthenoteratospermia
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