NCT03634644

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

August 12, 2018

Last Update Submit

September 8, 2021

Conditions

Male Infertility Due to Hypospermatogenesis

Keywords

male infertilityoligoasthenoteratospermia

Outcome Measures

Primary Outcomes (1)

  • sperm concentration

    sperm concentration

    40 days

Secondary Outcomes (1)

  • progressive ratio

    40 days

Other Outcomes (2)

  • DNA fragmentation index

    40 days

  • gut microbiota composition

    40 days

Study Arms (2)

Omega-3 fatty acid capsule

ACTIVE COMPARATOR

1g per capsule(EPA400mg，DHA320mg)

Drug: Omega 3 fatty acid

Placebo capsule

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

Omega 3 fatty acidDRUG

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

Also known as: Placebo Capsule
Omega-3 fatty acid capsule
Placebo oral capsuleDRUG

mainly composed of corn oil

Placebo capsule

Eligibility Criteria

Age21 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Oligoasthenoteratospermia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Reproductive Medicine, Jinling Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31900292DERIVED

MeSH Terms

Conditions

Infertility, Male

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Central Study Contacts

Bing Yao

CONTACT

86-25-80860174yaobing@nju.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Center for Reproductive Medicine

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 16, 2018

Study Start

November 8, 2017

Primary Completion

March 17, 2019

Study Completion

October 28, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

CN(1)