Effect of Omega 3 Fats on Sperm Quality and Sexual Function

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

Sponsors

Lead Sponsor: Reproductive Partners Medical Group

Source Reproductive Partners Medical Group
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.

Overall Status Terminated
Start Date January 2007
Completion Date December 2007
Primary Completion Date December 2007
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Questionaires regarding sexual function every 30 days
Semen analysis every 30 days
Secondary Outcome
Measure Time Frame
blood pressure every 30 days
serum nitrate levels every 30 days
Enrollment 6
Condition
Intervention

Intervention Type: Drug

Intervention Name: omega 3 fats

Description: 1,000 mg daily

Intervention Type: Drug

Intervention Name: folic acid

Description: 800 micrograms daily

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

Gender: Male

Minimum Age: 35 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
David R Meldrum, M.D. Principal Investigator Reproductive Partners Medical Group
Location
Facility: Reproductive Partners medical Group
Location Countries

United States

Verification Date

June 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Reproductive Partners Medical Group

Investigator Full Name: David R. Meldrum, M.D.

Investigator Title: Scientific Director

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov