- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03646825
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
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 Contact
- Name: Mandy Katz-Jaffe, PhD
- Phone Number: 303-788-8300
- Email: rmakloski@colocrm.com
Study Locations
-
-
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
|
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.
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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