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TerminatedNCT00406874Updated Jun 4, 2013

Effect of Omega 3 Fats on Sperm Quality and Sexual Function

A Phase 2 interventional study of omega 3 fats and folic acid in Infertility, sponsored by Reproductive Partners Medical Group. Terminated at 1 site in United States. Open to male participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-06-04.

Sponsored by Reproductive Partners Medical Group · Phase 2, Interventional, and Treatment

Why this study was terminated
reports indicating that increased folic acid intake may increase colin cancer
Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
35 Years to 55 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility

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Keywords

  • infertility
  • semen quality
  • sexual function
  • blood pressure
  • omega 3 fats
  • folic acid
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 6 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

This is the only study on the registry with Reproductive Partners Medical Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • infertile men
  • age 35 to 55
  • expressing difficulty timing relations to their partner's ovulation

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
6 participants (actual)

Interventions

  • Drugomega 3 fats

    1,000 mg daily

  • Drugfolic acid

    800 micrograms daily

06

What researchers measure

Primary outcomes

  1. Questionaires regarding sexual function

    Time frame: every 30 days

  2. Semen analysis

    Time frame: every 30 days

Secondary outcomes

  1. blood pressure

    Time frame: every 30 days

  2. serum nitrate levels

    Time frame: every 30 days

07

Study locations

1 site
  • Reproductive Partners medical Group
    Redondo beach, California 90277, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00406874
Lead sponsor
Reproductive Partners Medical Group
Responsible party
David R. Meldrum, M.D. (Scientific Director, Reproductive Partners Medical Group) — Principal investigator
First posted
Dec 4, 2006
Start date
Jan 2007
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Jun 4, 2013

Study contacts

David R Meldrum, M.D.
principal investigator · Reproductive Partners Medical Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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