Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

NCT ID: NCT03646825

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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

Conditions

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Observe Effect of Antioxidant on Sperm DNA Fragmention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment group

Male patients exposed to antioxidant for 12 weeks

Natural Antioxidant supplement

Intervention Type DIETARY_SUPPLEMENT

1 capsule orally three times a day for 12 weeks

Interventions

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Natural Antioxidant supplement

1 capsule orally three times a day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Severe male factor infertility
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Colorado Center for Reproductive Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Makloski

Role: STUDY_CHAIR

Study Coordinator

Locations

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Colorado Center for Reproductive Medicine

Lone Tree, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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20170532

Identifier Type: -

Identifier Source: org_study_id

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