Clinical trial NCT00406874: Effect of Omega 3 Fats on Sperm Quality and Sexual Function
Official title: Effect of Omega 3 Fats on Sperm Quality and Sexual Function in Infertile Men Age 35-55
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Infertility
Keywords: infertility
semen quality
sexual function
blood pressure
omega 3 fats
folic acid
Lead sponsor: Reproductive Partners Medical Group
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Questionaires regarding sexual function
timeFrame: every 30 days
measure: Semen analysis
timeFrame: every 30 days
Secondary outcomes:
measure: blood pressure
timeFrame: every 30 days
measure: serum nitrate levels
timeFrame: every 30 days
Other outcomes:
Locations:
city: Redondo beach
country: United States
facility: Reproductive Partners medical Group
state: California
Study officials:
affiliation: Reproductive Partners Medical Group
name: David R Meldrum, M.D.
role: PRINCIPAL_INVESTIGATOR
References: