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

June 14, 2015 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2
  • Phase 3

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

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DHA plus vitamin E
Cap DHA 460mg plus vitamin E 600mg per day
Dietary supplement: vitamin E
Dietary supplement: DHA
ACTIVE_COMPARATOR: VitaminE plus placebo
vitamin E 600 mg plus placebo
Other: placebo
Dietary supplement: vitamin E
PLACEBO_COMPARATOR: placebo plus placebo
DHA shaped placebo plus vitamin E shaped placebo
Other: placebo
ACTIVE_COMPARATOR: DHA plus placebo
460 mg DHA plus placebo
Other: placebo
Dietary supplement: DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sperm motility
Time Frame: 12 weeks
spermatogram
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sperm count
Time Frame: 12 weeks
spermatogram
12 weeks
seminal oxidative stress
Time Frame: 12 weeks
ELISA
12 weeks

Collaborators and Investigators

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

Sponsor

National Nutrition and Food Technology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2013

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (ESTIMATE)

May 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 14, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 046401

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.

Clinical Trials on Asthenozoospermia

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe