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

Phase 2

Completed

• Conditions: Asthenozoospermia
• Interventions: Dietary Supplement: vitamin E; Other: placebo; Dietary Supplement: DHA

• Registration Number: NCT01846325
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-03
• Study Start: 2013-12
• Primary Completion: 2015-02
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-14
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VitaminE plus placebo	vitamin E	vitamin E 600 mg plus placebo
placebo plus placebo	placebo	DHA shaped placebo plus vitamin E shaped placebo
DHA plus vitamin E	vitamin E	Cap DHA 460mg plus vitamin E 600mg per day
DHA plus vitamin E	DHA	Cap DHA 460mg plus vitamin E 600mg per day
VitaminE plus placebo	placebo	vitamin E 600 mg plus placebo
DHA plus placebo	DHA	460 mg DHA plus placebo
DHA plus placebo	placebo	460 mg DHA plus placebo

Primary Outcome Measures

Name	Time	Method
sperm motility	12 weeks	spermatogram

Secondary Outcome Measures

Name	Time	Method
sperm count	12 weeks	spermatogram
seminal oxidative stress	12 weeks	ELISA