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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DHA

Dietary Supplement

Other names: Docosahexaenoic acid

Placebo

Other

Primary outcomes

Sperm cell concentration

Time frame: Three months

Measured in millions of sperm cells per ml of semen sample
Sperm cell motility

Time frame: Three months

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

Time frame: Three

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

Sponsors and collaborators

Lead sponsor

Vida Recoletas Sevilla

Other

Registry information

Acronym: DHA

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2017
First posted: Sep 5, 2016
Registry last updated: Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed