Effect of Natural Antioxidant Supplement on Sperm DNA Fra... | NCT03646825

Studies
Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

NCT03646825

Sponsor

Colorado Center for Reproductive Medicine

Status

Terminated

Last Update Posted

Feb 23, 2023Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Observe Effect of Antioxidant on Sperm DNA Fragmention

Interventions

Natural Antioxidant supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Completed study with fewer participants than expected

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Jun 15, 2022Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

Aug 23, 2018

First Submission Date that Met QC Criteria

Aug 23, 2018

First Posted Date

Aug 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group		Male patients exposed to antioxidant for 12 weeks	Dietary Supplement: Natural Antioxidant supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Natural Antioxidant supplement	Dietary Supplement	1 capsule orally three times a day for 12 weeks	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sperm DNA fragmentation	Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Severe male factor infertility

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Male patients pursuing IVF for treatment of infertility

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Makloski	Study Coordinator	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Colorado Center for Reproductive Medicine		Lone Tree	Colorado	80124	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided