Infertility, MaleNCT05846256
Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
An observational study of Infertility, Male, run by Peter Humaidan at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Sperm DNA Fragmentation
- How many people
- 125 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Apr 2023to 1 Dec 2024
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men with unexplanied infertility undergoing fertility treatment
Who may be able to join
- Unexplained infertile men who will undergo 1st or 2nd IVF treatment
- Age over 18 years
- Normal sperm parameters according to WHO criteria
- IVF treatment
Who cannot join
- ICSI
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Fertility Clinic Regional Hospital Skive
Skive, 7800
Birgit Alsbjerg, M.D., +45 78 44 57 60, birgit.alsbjerg@midt.rm.dk
Alice Mikkelsen, Alice.Toft.Mikkelsen@midt.rm.dk
About this study
Official title: Evaluation of Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.
- Conditions
- Infertility, Male
- Being tested
- Sperm DNA Fragmentation
- Keywords
- Sperm DNA Fragmentation, Lifestyle, Doublestrand DNA Fragmentatio
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm DNA FragmentationOther
Sperm DNA Fragmentation analysis.
| Study group | Role | What they receive |
|---|---|---|
| Infertile male | Men with unexplained infertility Receives: Other: Sperm DNA Fragmentation | |
| Donors (control) | Fertile sperm donors Receives: Other: Sperm DNA Fragmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.
Sperm DNA Fragmentation done with a Comet Assay analysis
Measured: 30-60 minutes
Secondary outcomes (1)
The proportion of single-stranded DNA damage in sperm of men with unexplained infertility
Sperm DNA Fragmentation done with a Comet Assay analysis
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start25 Apr 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Collaborators
- ExamenLab Ltd
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846256
- Sponsor's protocol ID
- Doublestrand DNA Fragmentation
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
- ClinicalTrials.gov ID
- NCT05846256
- Acronym / sponsor ID
- Doublestrand DNA Fragmentation
- Conditions
- Infertility, Male
- Keywords
- Sperm DNA Fragmentation, Lifestyle, Doublestrand DNA Fragmentatio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Collaborators
- ExamenLab Ltd
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- 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.
The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertile male | – | Other: Sperm DNA FragmentationMen with unexplained infertility |
| Donors (control) | – | Other: Sperm DNA FragmentationFertile sperm donors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men with unexplanied infertility undergoing fertility treatment
Key inclusion criteria (4 listed)
- Unexplained infertile men who will undergo 1st or 2nd IVF treatment
- Age over 18 years
- Normal sperm parameters according to WHO criteria
- IVF treatment
Key exclusion criteria (1 listed)
- ICSI
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 |
|---|---|---|
| Sperm DNA FragmentationSperm DNA Fragmentation analysis. | Other | Donors (control), Infertile male |
Primary outcome
The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.
Time frame: 30-60 minutes
Sperm DNA Fragmentation done with a Comet Assay analysis
1 secondary outcome
The proportion of single-stranded DNA damage in sperm of men with unexplained infertility
Time frame: 30-60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Male, run by Peter Humaidan at 1 site in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Humaidan, Professor (78445760, peter.humaidan@midt.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of double-stranded DNA damage in sperm of men with unexplained infertility. (time frame: 30-60 minutes). 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 6 May 2023.