Effect of Omega 3 Fats on Sperm Quality and Sexual Function
Primary Purpose
Infertility
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
omega 3 fats
folic acid
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring infertility, semen quality, sexual function, blood pressure, omega 3 fats, folic acid
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
Sites / Locations
- Reproductive Partners medical Group
Outcomes
Primary Outcome Measures
Questionaires regarding sexual function
Semen analysis
Secondary Outcome Measures
blood pressure
serum nitrate levels
Full Information
NCT ID
NCT00406874
First Posted
November 30, 2006
Last Updated
June 3, 2013
Sponsor
Reproductive Partners Medical Group
1. Study Identification
Unique Protocol Identification Number
NCT00406874
Brief Title
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
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
reports indicating that increased folic acid intake may increase colin cancer
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Reproductive Partners Medical Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, semen quality, sexual function, blood pressure, omega 3 fats, folic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
omega 3 fats
Intervention Description
1,000 mg daily
Intervention Type
Drug
Intervention Name(s)
folic acid
Intervention Description
800 micrograms daily
Primary Outcome Measure Information:
Title
Questionaires regarding sexual function
Time Frame
every 30 days
Title
Semen analysis
Time Frame
every 30 days
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
every 30 days
Title
serum nitrate levels
Time Frame
every 30 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Meldrum, M.D.
Organizational Affiliation
Reproductive Partners Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Partners medical Group
City
Redondo beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Omega 3 Fats on Sperm Quality and Sexual Function
We'll reach out to this number within 24 hrs