Fertilix Supplements and Assisted Reproductive Technology

Spermatozoa Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02621125
• Other study ID #: Fertilix
• Status: Withdrawn
• Phase: N/A
• First received: December 1, 2015
• Last updated: May 1, 2017
• Start date: February 2016
• Est. completion date: February 2016

Study information

• Verified date: May 2017
• Source: University Reproductive Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spermatozoa

Intervention

Dietary Supplement:
• Fertilix
daily supplementation

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University Reproductive Associates	Hasbrouck Heights	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University Reproductive Associates	CellOxess LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in sperm DNA damage		2 years