Spermatozoa
Conditions
Brief summary
This is a double blind, randomized, placebo controlled clinical trial to test the efficacy of the antioxidant formulation Fertilix® in lowering the levels of damaged sperm DNA in men diagnosed with moderate to high Sperm Oxidative DNA Damage (SODD)
Interventions
OTHERPlacebo
Placebo
DIETARY_SUPPLEMENTFertilix
daily supplementation
Sponsors
CellOxess LLC
University Reproductive Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Males with a sperm sample containing 8-OHdG levels \> 15% and must be capable of producing an ejaculate containing \>10million sperm upon study enrollment. * Male is between 20-55 years of age seeking treatment for infertility with his partner at URA and who is a candidate for an IUI, IVF or IVF-ICSI (excluding donor egg) procedure. * Female is between 20-42 years of age * Female exhibits tubal patency on hydrosonogram or hysterosalpingogram (HSG) * Female exhibits normal uterine cavity by hysteroscopy, hydrosonogram or hysterosalpingogram (HSG).
Exclusion criteria
* Subjects with initial semen analysis of an ejaculate containing \< 10 million sperm. * Men who have been taking nutraceuticals, vitamins or other compounds known to have antioxidant activities within4 weeks of the study. No other supplements may be taken with Fertilix. * Men who have hypersensitivity or an allergy to any of the ingredients in Fertilix®. * Men who have been treated with a chemotherapeutic agent known to cause sterility, such as cyclophosphamide. * Men who have taking anabolic steroids or testosterone replacement within 4 months of the study. * Men currently being treated with a Ca++ channel blocker or other medical treatment known to adversely affect sperm production or function. * Men with HIV, hepatitis B and C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in sperm DNA damage | 2 years |
Countries
United States
Outcome results
None listed