Fertilix Supplements and Assisted Reproductive Technology

NCT ID: NCT02621125

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Spermatozoa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fertilix

Fertilix supplementation

Group Type EXPERIMENTAL

Fertilix

Intervention Type DIETARY_SUPPLEMENT

daily supplementation

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Fertilix

daily supplementation

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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CellOxess LLC

INDUSTRY

Sponsor Role collaborator

University Reproductive Associates

OTHER

Sponsor Role lead

Responsible Party

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Peter McGovern, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Reproductive Associates

Hasbrouck Heights, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Fertilix

Identifier Type: -

Identifier Source: org_study_id

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