Fertilix Supplements and Assisted Reproductive Technology

Not Applicable

Withdrawn

• Conditions: Spermatozoa
• Interventions: Dietary Supplement: Fertilix; Other: Placebo

• Registration Number: NCT02621125
• Lead Sponsor: University Reproductive Associates

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Study Start: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fertilix	Fertilix	Fertilix supplementation
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Reduction in sperm DNA damage	2 years

Trial Locations

Locations (1)

University Reproductive Associates; 🇺🇸 Hasbrouck Heights, New Jersey, United States