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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

Sponsor
National Nutrition and Food Technology Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01846325
Collaborator
(none)
180
Enrollment
4
Arms
17
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: vitamin E
  • Dietary Supplement: DHA
  • Other: placebo
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: DHA plus vitamin E

Cap DHA 460mg plus vitamin E 600mg per day

Dietary Supplement: vitamin E

Dietary Supplement: DHA
Active Comparator: VitaminE plus placebo

vitamin E 600 mg plus placebo

Dietary Supplement: vitamin E

Other: placebo
Placebo Comparator: placebo plus placebo

DHA shaped placebo plus vitamin E shaped placebo

Other: placebo
Active Comparator: DHA plus placebo

460 mg DHA plus placebo

Dietary Supplement: DHA

Other: placebo

Outcome Measures

Primary Outcome Measures

  1. sperm motility [12 weeks]

    spermatogram

Secondary Outcome Measures

  1. sperm count [12 weeks]

    spermatogram

  2. seminal oxidative stress [12 weeks]

    ELISA

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Azita Hekmatdoost, Dr, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT01846325
Other Study ID Numbers:
  • 046401
First Posted:
May 3, 2013
Last Update Posted:
Jun 16, 2015
Last Verified:
Jun 1, 2015
Additional relevant MeSH terms:
Asthenozoospermia
Vitamin E

Study Results

No Results Posted as of Jun 16, 2015