Infertile MenNCT02252510
Reliability for the Detection of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)
An observational study of Infertile Men, run by University Hospital, Clermont-Ferrand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Infertile Men
- What is being tested?
- HALOSPERM
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Study population: infertile men
Who may be able to join
- infertile men
- <50 years
- with at least 5.106spermatozoa/ml in the ejacu
Who cannot join
- azoospermia
About this study
Official title: Evaluation of the Reliability for the Measurement of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)
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.
Read the 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.
- Conditions
- Infertile Men
- Being tested
- HALOSPERM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HALOSPERMOther
What is being measured
The primary outcome is the main question the study is designed to answer.
- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)
Measured: at day 1
Secondary outcomes (1)
Percentage of sperm DNA damage measured by TUNEL method
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile MenStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252510
- Sponsor's protocol ID
- CHU-0208
- Status last verified
- Sep 2014
- First submitted
- 26 Sep 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reliability for the Measurement of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)
- ClinicalTrials.gov ID
- NCT02252510
- Acronym / sponsor ID
- CHU-0208
- Conditions
- Infertile Men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- infertile men
Key inclusion criteria (3 listed)
- infertile men
- <50 years
- with at least 5.106spermatozoa/ml in the ejacu
Key exclusion criteria (1 listed)
- azoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HALOSPERM | Other | – |
Primary outcome
- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)
Time frame: at day 1
1 secondary outcome
Percentage of sperm DNA damage measured by TUNEL method
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertile Men, run by University Hospital, Clermont-Ferrand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test) (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.