NCT02621125

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)

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

Same day

First QC Date

December 1, 2015

Last Update Submit

May 1, 2017

Conditions

Spermatozoa

Outcome Measures

Primary Outcomes (1)

  • Reduction in sperm DNA damage

    2 years

Study Arms (2)

Fertilix

EXPERIMENTAL

Fertilix supplementation

Dietary Supplement: Fertilix

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

FertilixDIETARY_SUPPLEMENT

daily supplementation

Fertilix
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Reproductive Associates

Hasbrouck Heights, New Jersey, 07604, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 3, 2015

Study Start

February 1, 2016

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

US(1)