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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01846325
Other study ID # 046401
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received May 1, 2013
Last updated June 14, 2015
Start date December 2013
Est. completion date May 2015

Study information

Verified date June 2015
Source National Nutrition and Food Technology Institute
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date May 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
vitamin E

DHA

Other:
placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Outcome

Type Measure Description Time frame Safety issue
Primary sperm motility spermatogram 12 weeks No
Secondary sperm count spermatogram 12 weeks No
Secondary seminal oxidative stress ELISA 12 weeks No
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