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Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646825
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Colorado Center for Reproductive Medicine

Tracking Information
First Submitted Date August 23, 2018
First Posted Date August 24, 2018
Last Update Posted Date July 10, 2020
Actual Study Start Date August 1, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2018)
Sperm DNA fragmentation [ Time Frame: 12 weeks ]
Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation
Official Title Observation Study of the Effect of Use of Natural Antioxidant Supplement on Sperm DNA Fragmentation
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male patients pursuing IVF for treatment of infertility
Condition Observe Effect of Antioxidant on Sperm DNA Fragmention
Intervention Dietary Supplement: Natural Antioxidant supplement
1 capsule orally three times a day for 12 weeks
Study Groups/Cohorts Treatment group
Male patients exposed to antioxidant for 12 weeks
Intervention: Dietary Supplement: Natural Antioxidant supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 23, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe male factor infertility
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Mandy Katz-Jaffe, PhD 303-788-8300 rmakloski@colocrm.com
Contact: Rachel Makloski 303-788-8300 ext 1769 rmakloski@colocrm.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03646825
Other Study ID Numbers 20170532
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Colorado Center for Reproductive Medicine
Study Sponsor Colorado Center for Reproductive Medicine
Collaborators Not Provided
Investigators
Study Chair: Rachel Makloski Study Coordinator
PRS Account Colorado Center for Reproductive Medicine
Verification Date July 2020