Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

February 22, 2023 updated by: Colorado Center for Reproductive Medicine

Observation Study of the Effect of Use of Natural Antioxidant Supplement on Sperm DNA Fragmentation

Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Male patients will be recruited based on having a high DNA fragmentation (chromatin >16) no other severe male factor infertility (>5million/ml, count, > 10%motility and >1% morphology) and sufficient ejaculate sperm for ICSI (no surgically removed sperm or history of vasectomy reversal). Patients will be provided the natural antioxidant supplementation by the sponsor. Patients will take 1 capsule orally 3 times a day for a full 12 weeks. Sperm DNA structure will be re-assessed after completion of 12 weeks of antioxidant to compare to baseline sperm DNA structure collected prior to starting regimen of supplement daily

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Colorado Center for Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male patients pursuing IVF for treatment of infertility

Description

Inclusion Criteria:

-Sperm Chromatin >16%, sufficient ejaculate sperm for ICSI

Exclusion Criteria:

  • Severe male factor infertility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group
Male patients exposed to antioxidant for 12 weeks
Dietary supplement: Natural Antioxidant supplement
1 capsule orally three times a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm DNA fragmentation
Time Frame: 12 weeks
Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Center for Reproductive Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

August 23, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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