Effect of Omega 3 Fats on Sperm Quality and Sexual Function

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00406874
• Other study ID #: RPMG-1
• Status: Terminated
• Phase: Phase 2
• First received: November 30, 2006
• Last updated: June 3, 2013
• Start date: January 2007
• Est. completion date: December 2007

Study information

• Verified date: June 2013
• Source: Reproductive Partners Medical Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• omega 3 fats
1,000 mg daily
• folic acid
800 micrograms daily

Locations

Country	Name	City	State
United States	Reproductive Partners medical Group	Redondo beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Partners Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionaires regarding sexual function		every 30 days	No
Primary	Semen analysis		every 30 days	No
Secondary	blood pressure		every 30 days	No
Secondary	serum nitrate levels		every 30 days	No