Reliability for the Detection of Sperm DNA Damage by a Sp... | NCT02252510

Studies
Reliability for the Detection of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)

NCT02252510

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Sep 30, 2014Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Infertile Men

Interventions

HALOSPERM

Countries

Not provided

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Sep 26, 2014

First Submission Date that Met QC Criteria

Sep 26, 2014

First Posted Date

Sep 30, 2014Estimated

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

Sep 26, 2014

Last Update Posted Date

Sep 30, 2014Estimated

Description Module

Brief Summary

It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This measurement helps to better diagnose male infertility and seems easy to apply in routine. However, the reliability of this method needs to be evaluated before applying for clinical practice in andrology laboratory.

Detailed Description

The aim of this study is to measure the inter and intra-observer reliability for the measurements of sperm DNA damage by sperm chromatin dispersion test (halosperm). The gold standard to measure sperm DNA damage is TUNEL (Terminal desoxynucleotidyl end labelling) method. However, this method is not easy to apply in routine. Therefore we investigate to analyse the inter-method reliability between sperm chromatin dispersion test and TUNEL.

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

40Actual

Name	Type	Description	Arm Group Labels	Other Names
HALOSPERM	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)		at day 1

Secondary Outcomes

Measure	Description	Time Frame
Percentage of sperm DNA damage measured by TUNEL method		at day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infertile men
<50 years
with at least 5.106spermatozoa/ml in the ejacu

Exclusion Criteria:

azoospermia

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

infertile men

Sampling Method

Non-Probability Sample