Fertilix Supplements and Assisted Reproductive Technology
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Spermatozoa
In brief
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)
Key facts
- Study ID
- NCT02621125
- Run by
- University Reproductive Associates
- People needed
- 0
- Starts
- 2016-02-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2017-05-02
Who can join
Age: 20 and older, up to 55. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- University Reproductive Associates — Hasbrouck Heights, New Jersey, United States
Full record on ClinicalTrials.gov
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