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

NCT ID: NCT01846325

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthenozoospermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DHA plus vitamin E

Cap DHA 460mg plus vitamin E 600mg per day

Group Type EXPERIMENTAL

vitamin E

Intervention Type DIETARY_SUPPLEMENT

DHA

Intervention Type DIETARY_SUPPLEMENT

VitaminE plus placebo

vitamin E 600 mg plus placebo

Group Type ACTIVE_COMPARATOR

vitamin E

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type OTHER

placebo plus placebo

DHA shaped placebo plus vitamin E shaped placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

DHA plus placebo

460 mg DHA plus placebo

Group Type ACTIVE_COMPARATOR

DHA

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type OTHER

Interventions

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vitamin E

Intervention Type DIETARY_SUPPLEMENT

DHA

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 32453396 (View on PubMed)

Other Identifiers

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046401

Identifier Type: -

Identifier Source: org_study_id

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