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OpenTrials
Completed

NCT Number: NCT01846325

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

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.

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Key information

Conditions

Asthenozoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Dietary Supplement

DHA

Dietary Supplement

Placebo

Other

Primary outcomes

  1. sperm motility

    Time frame: 12 weeks

    spermatogram

Secondary outcomes

  1. sperm count

    Time frame: 12 weeks

    spermatogram

  2. seminal oxidative stress

    Time frame: 12 weeks

    ELISA

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 3, 2013
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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