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The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia

Primary Purpose

Asthenozoospermia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
vitamin E
DHA
placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthenozoospermia

Eligibility Criteria

20 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion criteria:

  • Willing to participate in the study and filling out the informed consent form
  • should be infertile (no conception after 12 months intercourse without any contraception)
  • age 20-45 y.o, idiopathic asthenospermia according to WHO criteria
  • normal hormonal profile

Exclusion criteria:

  • any infection in genitourinary (GU) tract
  • any anatomical abnormality in GU tract
  • any chronic disease during last 3 months
  • any surgery in GU tract
  • consumption of omega-3 fatty acids and/or vitamin E supplements during last 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    DHA plus vitamin E

    VitaminE plus placebo

    placebo plus placebo

    DHA plus placebo

    Arm Description

    Cap DHA 460mg plus vitamin E 600mg per day

    vitamin E 600 mg plus placebo

    DHA shaped placebo plus vitamin E shaped placebo

    460 mg DHA plus placebo

    Outcomes

    Primary Outcome Measures

    sperm motility
    spermatogram

    Secondary Outcome Measures

    sperm count
    spermatogram
    seminal oxidative stress
    ELISA

    Full Information

    First Posted
    May 1, 2013
    Last Updated
    June 14, 2015
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01846325
    Brief Title
    The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Nutrition and Food Technology Institute

    4. Oversight

    5. Study Description

    Brief Summary
    Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds which are susceptible to oxidation and production of free oxygen radicals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthenozoospermia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DHA plus vitamin E
    Arm Type
    Experimental
    Arm Description
    Cap DHA 460mg plus vitamin E 600mg per day
    Arm Title
    VitaminE plus placebo
    Arm Type
    Active Comparator
    Arm Description
    vitamin E 600 mg plus placebo
    Arm Title
    placebo plus placebo
    Arm Type
    Placebo Comparator
    Arm Description
    DHA shaped placebo plus vitamin E shaped placebo
    Arm Title
    DHA plus placebo
    Arm Type
    Active Comparator
    Arm Description
    460 mg DHA plus placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    vitamin E
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    DHA
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    sperm motility
    Description
    spermatogram
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    sperm count
    Description
    spermatogram
    Time Frame
    12 weeks
    Title
    seminal oxidative stress
    Description
    ELISA
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Willing to participate in the study and filling out the informed consent form should be infertile (no conception after 12 months intercourse without any contraception) age 20-45 y.o, idiopathic asthenospermia according to WHO criteria normal hormonal profile Exclusion criteria: any infection in genitourinary (GU) tract any anatomical abnormality in GU tract any chronic disease during last 3 months any surgery in GU tract consumption of omega-3 fatty acids and/or vitamin E supplements during last 3 months

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32453396
    Citation
    Eslamian G, Amirjannati N, Noori N, Sadeghi MR, Hekmatdoost A. Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial. Am J Clin Nutr. 2020 Sep 1;112(3):707-719. doi: 10.1093/ajcn/nqaa124.
    Results Reference
    derived

    Learn more about this trial

    The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia

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