Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

NCT03646825 | Terminated

• 1 other identifier: 20170532
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Observe Effect of Antioxidant on Sperm DNA Fragmention

Outcome Measures

Primary Outcomes (1)

• Sperm DNA fragmentation

  Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure

  12 weeks

Study Arms (1)

Treatment group

Male patients exposed to antioxidant for 12 weeks

Dietary Supplement: Natural Antioxidant supplement

Interventions

Natural Antioxidant supplement DIETARY_SUPPLEMENT

1 capsule orally three times a day for 12 weeks

Treatment group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male patients pursuing IVF for treatment of infertility

You may qualify if:

• Sperm Chromatin \>16%, sufficient ejaculate sperm for ICSI

You may not qualify if:

• Severe male factor infertility

Sponsors & Collaborators

• Colorado Center for Reproductive Medicine: lead

Study Sites (1)

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, 80124, United States

Location

Study Officials

• Rachel Makloski

  Study Coordinator

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: August 1, 2018
• Primary Completion: June 15, 2022
• Study Completion: October 1, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)