Effect of Omega 3 Fats on Sperm Quality and Sexual Function

June 3, 2013 updated by: David R. Meldrum, M.D., Reproductive Partners Medical Group

Effect of Omega 3 Fats on Sperm Quality and Sexual Function in Infertile Men Age 35-55

This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. It will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic acid.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Infertile men commonly have difficulty timing sexual relations around the time of ovulation. There is a high incidence of abnormal sperm morphology in infertile men. Omega 3 fats are known to increase the production of nitric oxide, which is the mediator of the male response, and folic acid is an important cofactor in the production of nitric oxide. Omega 3 fats are also important in the structure and function of cell membranes. There is a high incidence of deficient intake of omega 3 fats and folic acid in the U.S. population. Both folic acid and omega 3 fats are available as nutritional supplements and the doses used in this study are doses commonly recommended as nutritional supplements.

Comparison: Omega 3 fats plus folic acid will be compared with placebo plus folic acid in men age 35 to 55 attempting pregnancy with normal or mildly impaired semen quality. They will fill out dietary questionaires, questionaires regarding sexual function, and will have measurements of serum nitrates, blood pressure, and semen quality before and during use of these nutritional supplements. In men continuing on both omega 3 fats and folic acid, we will compare the effects of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo on their sexual function.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redondo beach, California, United States, 90277
        • Reproductive Partners medical Group

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

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • infertile men
  • age 35 to 55
  • expressing difficulty timing relations to their partner's ovulation

Exclusion Criteria:

  • hypertension, heart disease or other systemic diseases
  • fatty fish intake more than twice per week
  • marked semen abnormalities (less than 10 million sperm per ml, less than 20 % A plus B motility, more than 1 million WBC per HPF)
  • use of anticoagulants
  • must be willing to not take PDE 5 inhibitors during the study
  • use of other supplements is prohibited during the study

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: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Questionaires regarding sexual function
Time Frame: every 30 days
every 30 days
Semen analysis
Time Frame: every 30 days
every 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: every 30 days
every 30 days
serum nitrate levels
Time Frame: every 30 days
every 30 days

Collaborators and Investigators

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

Sponsor

Reproductive Partners Medical Group

Investigators

  • Principal Investigator: David R Meldrum, M.D., Reproductive Partners medical Group

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

January 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

December 1, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPMG-1

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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