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

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Asthenozoospermia

Treatments: Dietary Supplement: vitamin E; Dietary Supplement: DHA; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01846325

046401

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups, including a placebo group

DHA plus vitamin E

Experimental group

Description:

Cap DHA 460mg plus vitamin E 600mg per day

Treatment:

Dietary Supplement: vitamin E

Dietary Supplement: DHA

VitaminE plus placebo

Active Comparator group

Description:

vitamin E 600 mg plus placebo

Treatment:

Dietary Supplement: vitamin E

Other: placebo

placebo plus placebo

Placebo Comparator group

Description:

DHA shaped placebo plus vitamin E shaped placebo

Treatment:

Other: placebo

DHA plus placebo

Active Comparator group

Description:

460 mg DHA plus placebo

Treatment:

Dietary Supplement: DHA

Other: placebo