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Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

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ClinicalTrials.gov Identifier: NCT03646825
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Colorado Center for Reproductive Medicine

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.

Condition or disease Intervention/treatment
Observe Effect of Antioxidant on Sperm DNA Fragmention Dietary Supplement: Natural Antioxidant supplement

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observation Study of the Effect of Use of Natural Antioxidant Supplement on Sperm DNA Fragmentation
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sperm DNA fragmentation [ Time Frame: 12 weeks ]
    Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Non-Probability Sample
Study Population
Male patients pursuing IVF for treatment of infertility
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe male factor infertility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646825


Contacts
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Contact: Mandy Katz-Jaffe, PhD 303-788-8300 rmakloski@colocrm.com
Contact: Rachel Makloski 303-788-8300 ext 1769 rmakloski@colocrm.com

Locations
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United States, Colorado
Colorado Center for Reproductive Medicine Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Rachel Makloski, RN       maleacai@colocrm.com   
Sponsors and Collaborators
Colorado Center for Reproductive Medicine
Investigators
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Study Chair: Rachel Makloski Study Coordinator

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Responsible Party: Colorado Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT03646825     History of Changes
Other Study ID Numbers: 20170532
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs