NCT02252510

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

September 26, 2014

Last Update Submit

September 26, 2014

Conditions

Infertile Men

Outcome Measures

Primary Outcomes (1)

  • - Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)

    at day 1

Secondary Outcomes (1)

  • Percentage of sperm DNA damage measured by TUNEL method

    at day 1

Interventions

HALOSPERMOTHER

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

infertile men

You may qualify if:

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

You may not qualify if:

  • azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

September 30, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

September 30, 2014

Record last verified: 2014-09