Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility

Vida Recoletas Sevilla60 enrolled

Overview

Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.

Prospective, randomized, double blind, placebo-controlled intervention study within individuals. Assisted reproduction unit and academic research laboratory. One hundred an eighty human semen samples from 60 infertile patients of IVI Sevilla clinic were finally included. Assessment of oxidative stress, apoptosis, lipid peroxidation, mitochondrial membrane potential, DNA fragmentation and standard sperm parameters before and after supplementation with different DHA doses (0.5, 1 and 2 g) or placebo for 1 and 3 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Male Infertility

Interventions

DHADIETARY_SUPPLEMENT

PlaceboOTHER

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion criteria: * 1 year of infertility * \> 10 mill/ml of sperms * Motility \< 60% progressive * Morphology \< 2% (WHO 2010) Exclusion criteria: No meeting the inclusion criteria.

Outcomes

Primary Outcomes

Sperm cell concentration

Measured in millions of sperm cells per ml of semen sample

Time frame: Three months

Sperm cell motility

Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).

Time frame: Three months

Sperm cell morphology

Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.

Time frame: Three

Data from ClinicalTrials.gov

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