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

Asthenozoospermia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846325
• Other study ID #: 046401
• 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

• Asthenozoospermia

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