InfertilityReproDNANCT04160208
DNA Damage and Subfertility in Males - Impact on ART Outcome
An observational study of Infertility, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
Trial summary
A obvational prospective cohort study of men undergoing IUI, IVF and ICSI treatment in Denmark. The aim is to asses the impact of sperm DNA damage, measured as DNA fragmentation index (DFI), on reproductive outcomes after assisted reproductive technology (ART). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infertility
- How many people
- 1,350 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2019to 1 Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Males of couples attending Skive fertility Clinic
Who may be able to join
- First cycle treatment
Who cannot join
- TESA/PESA, more than one cycle
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Fertility Clinic, Skive Regional Hospital
Skive
Peter Humaidan, DMSc, +4578445760, fertilitetsklinikken@midt.rm.dk
About this study
Official title: DNA Damage and Subfertility in Males - Impact on Assisted Reproductive Treatment Outcome
A obvational prospective cohort study of men undergoing IUI, IVF and ICSI treatment in Denmark. The aim is to asses the impact of sperm DNA damage, measured as DNA fragmentation index (DFI), on reproductive outcomes after assisted reproductive technology (ART).
- Conditions
- Infertility
- Keywords
- male infertility, DNA fragmentation Index, DFI
- 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.
| Study group | Role | What they receive |
|---|---|---|
| IUI - Insemination | Males of couples undergoing their first IUI treatment | |
| IVF - In vitro fertilisation | Males of couples undergoing their first IVF treatment. Including males of couples who have had previous IUI treatments. | |
| ICSI - Micro Insemination | Males of couples undergoing their first ICSI treatment. Including males of couples who have had previous IUI treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of particpants achieving live birth
Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.
Measured: week 23-42 of pregnancy
Secondary outcomes (3)
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 posted12 Nov 2019
- Study start1 Oct 2019
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,350 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
- NCT04160208
- Sponsor's protocol ID
- DFI2019Skivecohort
- Acronym
- ReproDNA
- Status last verified
- Jul 2023
- First submitted
- 8 Nov 2019
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Damage and Subfertility in Males - Impact on Assisted Reproductive Treatment Outcome
- ClinicalTrials.gov ID
- NCT04160208
- Acronym / sponsor ID
- ReproDNA / DFI2019Skivecohort
- Conditions
- Infertility
- Keywords
- male infertility, DNA fragmentation Index, DFI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Regionshospitalet Viborg, SkiveUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 12 Nov 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 obvational prospective cohort study of men undergoing IUI, IVF and ICSI treatment in Denmark. The aim is to asses the impact of sperm DNA damage, measured as DNA fragmentation index (DFI), on reproductive outcomes after assisted reproductive technology (ART).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IUI - Insemination | – | –Males of couples undergoing their first IUI treatment |
| IVF - In vitro fertilisation | – | –Males of couples undergoing their first IVF treatment. Including males of couples who have had previous IUI treatments. |
| ICSI - Micro Insemination | – | –Males of couples undergoing their first ICSI treatment. Including males of couples who have had previous IUI treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males of couples attending Skive fertility Clinic
Key inclusion criteria (1 listed)
- First cycle treatment
Key exclusion criteria (1 listed)
- TESA/PESA, more than one cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of particpants achieving live birth
Time frame: week 23-42 of pregnancy
Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.
3 secondary outcomes
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 6 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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, 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 6 Jul 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?
Number of particpants achieving live birth (time frame: week 23-42 of pregnancy). 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 Jul 2023.