Single and Double DNA Strand Breaks in Males With Unexpla... | NCT05846256

Studies
Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

NCT05846256

Sponsor

Peter Humaidan

Status

Unknown status

Last Update Posted

May 6, 2023Actual

Enrollment

125Estimated

Phase

Not provided

Conditions

Infertility, Male

Interventions

Sperm DNA Fragmentation

Countries

Denmark

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2023Actual

Primary Completion Date

May 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Apr 26, 2023

First Submission Date that Met QC Criteria

Apr 26, 2023

First Posted Date

May 6, 2023Actual

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

Apr 26, 2023

Last Update Posted Date

May 6, 2023Actual

Name	Class
ExamenLab Ltd	UNKNOWN

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

The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.

Detailed Description

Not provided

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

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infertile male		Men with unexplained infertility	Other: Sperm DNA Fragmentation
Donors (control)		Fertile sperm donors	Other: Sperm DNA Fragmentation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sperm DNA Fragmentation	Other	Sperm DNA Fragmentation analysis.	Donors (control) Infertile male

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.	Sperm DNA Fragmentation done with a Comet Assay analysis	30-60 minutes

Secondary Outcomes

Measure	Description	Time Frame
The proportion of single-stranded DNA damage in sperm of men with unexplained infertility	Sperm DNA Fragmentation done with a Comet Assay analysis	30-60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unexplained infertile men who will undergo 1st or 2nd IVF treatment
Age over 18 years
Normal sperm parameters according to WHO criteria
IVF treatment

Exclusion Criteria:

- ICSI

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men with unexplanied infertility undergoing fertility treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Humaidan, Professor	Contact	78445760		peter.humaidan@midt.rm.dk
Mette Jensen, Research assistant	Contact	78445718		mejen8@rm.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertility Clinic Regional Hospital Skive	Recruiting	Skive		7800	Denmark

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

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

Not provided

Browse Branches

Not provided