Fertilix Supplements and Assisted Reproductive Technology

University Reproductive Associates

Status

Withdrawn

Conditions

Spermatozoa

Treatments

Other: Placebo

Dietary Supplement: Fertilix

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02621125

Fertilix

Details and patient eligibility

About

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)

Sex

Male

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.