InfertilityReproDNANCT04183374
DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health
A study testing Life style in people with Infertility, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
Trial summary
A lifestyle intervention study in infertile males of couples seeking fertility treatment with a DNA fragmentation index (DFI) above 15 percentage. A reduction in DNA fragmentation index of 10 percentage points is expected after 3-4 months of intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infertility
- What is being tested?
- Life style
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2019to 1 Feb 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DNA fragmentation index above 15 %
Who cannot join
- TESA/PESA
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Fertility Clinic Skive, Skive Regional Hospital
Skive, 7800
Peter Humaidan, DMSc, +4578445760, fertilitetsklinikken@midt.rm.dk
About this study
A lifestyle intervention study in infertile males of couples seeking fertility treatment with a DNA fragmentation index (DFI) above 15 percentage. A reduction in DNA fragmentation index of 10 percentage points is expected after 3-4 months of intervention.
- Conditions
- Infertility
- Being tested
- Life style
- Keywords
- male infertility, DNA fragmentation Index, DFI, life style intervention
- Medical subject headings
- Infertility, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life styleOther
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation Receives: Other: Life style |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DNA fragmentation index (DFI)
DFI is measured by SCSA
Measured: 3-4 months after inclusion
Secondary outcomes (14)
Change in classical sperm parameters
Sperm count
Measured: 3-4 months after inclusion
Change in classical sperm parameters
Sperm motility (movement)
Measured: 3-4 months after inclusion
Change in classical sperm parameters
Sperm morphology (structure)
Measured: 3-4 months after inclusion
Change in classical sperm parameters
Sperm concentration in mio sperm pr. milliliter
Measured: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Weight in kilograms
Measured: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Blood pressure in millimeters of mercury
Measured: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Hemoglobin A1c in mmol/L
Measured: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Body mass index in kg/m^2
Measured: 3-4 months after inclusion
Change in plasma lipids
Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Measured: 3-4 months after inclusion
Change in serum D-vitamin levels
25-hydroxy vitamin D (D3+D2) measured as nmol/l
Measured: 3-4 months after inclusion
Number of participants achieving live birth
Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.
Measured: Week 30-42 of pregnancy
Number of participants with clinical pregnancy
Measurement of heart beat by ultrasound scan
Measured: Week 7-8 of pregnancy
Number of participants with biochemical pregnancy
Increase in serum hCG levels
Measured: Day 14-17 of pregnancy
Cumulative live birth rate
Live births originating from one controlled stimulation.
Measured: 9-24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Oct 2019
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Viborg, Skive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183374
- Sponsor's protocol ID
- DFI2019Skiveintervention
- Acronym
- ReproDNA
- Status last verified
- Apr 2023
- First submitted
- 8 Nov 2019
- Last updated
- 27 Apr 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health
- ClinicalTrials.gov ID
- NCT04183374
- Acronym / sponsor ID
- ReproDNA / DFI2019Skiveintervention
- Conditions
- Infertility
- Keywords
- male infertility, DNA fragmentation Index, DFI, life style intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Regionshospitalet Viborg, SkiveUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 3 Dec 2019 (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.
A lifestyle intervention study in infertile males of couples seeking fertility treatment with a DNA fragmentation index (DFI) above 15 percentage. A reduction in DNA fragmentation index of 10 percentage points is expected after 3-4 months of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Life styleLifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DNA fragmentation index above 15 %
Key exclusion criteria (1 listed)
- TESA/PESA
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 |
|---|---|---|
| Life styleLifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation | Other | Intervention |
Primary outcome
Change in DNA fragmentation index (DFI)
Time frame: 3-4 months after inclusion
DFI is measured by SCSA
14 secondary outcomes
Change in classical sperm parameters
Time frame: 3-4 months after inclusion
Change in classical sperm parameters
Time frame: 3-4 months after inclusion
Change in classical sperm parameters
Time frame: 3-4 months after inclusion
Change in classical sperm parameters
Time frame: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Time frame: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Time frame: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Time frame: 3-4 months after inclusion
Changes in parameters for metabolic syndrome
Time frame: 3-4 months after inclusion
Change in plasma lipids
Time frame: 3-4 months after inclusion
Change in serum D-vitamin levels
Time frame: 3-4 months after inclusion
Number of participants achieving live birth
Time frame: Week 30-42 of pregnancy
Number of participants with clinical pregnancy
Time frame: Week 7-8 of pregnancy
Number of participants with biochemical pregnancy
Time frame: Day 14-17 of pregnancy
Cumulative live birth rate
Time frame: 9-24 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
Fertility Clinic Skive, Skive Regional Hospital
Skive, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life style in people with Infertility, run by Regionshospitalet Viborg, Skive 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 1 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 27 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DNA fragmentation index (DFI) (time frame: 3-4 months after inclusion). 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 27 Apr 2023.