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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01846325
Enrollment
180
Registered
2013-05-03
Start date
2013-12-31
Completion date
2015-05-31
Last updated
2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthenozoospermia

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.

Interventions

DIETARY_SUPPLEMENTvitamin E
DIETARY_SUPPLEMENTDHA
OTHERplacebo

Sponsors

National Nutrition and Food Technology Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
sperm motility12 weeksspermatogram

Secondary

MeasureTime frameDescription
sperm count12 weeksspermatogram
seminal oxidative stress12 weeksELISA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026