Effect of Omega 3 Fats on Sperm Quality and Sexual Function

NCT ID: NCT00406874

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-12-31

Brief Summary

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.

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

omega 3 fats

1,000 mg daily

Intervention Type: DRUG

folic acid

800 micrograms daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Reproductive Partners Medical Group

OTHER

Sponsor Role: lead

Responsible Party

David R. Meldrum, M.D.

Scientific Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R Meldrum, M.D.

Role: PRINCIPAL_INVESTIGATOR

Reproductive Partners Medical Group

Locations

Reproductive Partners medical Group

Redondo Beach, California, United States

Countries

United States

Other Identifiers

RPMG-1

Identifier Type: -

Identifier Source: org_study_id