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

August 1, 2017 updated by: IVI Sevilla
Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Active Comparator: 500 mg DHA/day
Dietary supplement: DHA
Other Names:
  • Docosahexaenoic acid
Active Comparator: 1g DHA/day
Dietary supplement: DHA
Other Names:
  • Docosahexaenoic acid
Active Comparator: 2g DHA/day
Dietary supplement: DHA
Other Names:
  • Docosahexaenoic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm cell concentration
Time Frame: Three months
Measured in millions of sperm cells per ml of semen sample
Three months
Sperm cell motility
Time Frame: Three months
Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).
Three months
Sperm cell morphology
Time Frame: Three
Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.
Three

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Sevilla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2013

Primary Completion (Actual)

May 26, 2015

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1303-SEV-00-CG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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