Infertility, MaleNCT05397314
DNA Fragmentation - Effect on Pregnancy Rate
A study testing Punalpin in people with Infertility, Male, run by Odense University Hospital.
Trial summary
The purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Punalpin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 9 Apr 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male fertility patients with increased amount of DNA fragmentation in their spermatozoa
Who cannot join
- -
About this study
The purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Secondary purpose is to investigate whether there is any positive effect on the subsequent pregnancy rates from the fertility treatment.
- Conditions
- Infertility, Male
- Being tested
- Punalpin, Placebo
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PunalpinDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Punalpin | Experimental | Not described Receives: Dietary Supplement: Punalpin |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm DNA fragmentation
Reduction in DNA fragmentation
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jan 2016
- Primary completion9 Jan 2021
- Study completion9 Apr 2021
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.
- More trials run by Odense University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Fedder, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397314
- Sponsor's protocol ID
- S-20140212
- Status last verified
- May 2022
- First submitted
- 15 Oct 2019
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Fragmentation - Effect on Pregnancy Rate
- ClinicalTrials.gov ID
- NCT05397314
- Acronym / sponsor ID
- S-20140212
- Conditions
- Infertility, Male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 31 May 2022 (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 purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Secondary purpose is to investigate whether there is any positive effect on the subsequent pregnancy rates from the fertility treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Punalpin | Experimental | Dietary Supplement: Punalpin |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male fertility patients with increased amount of DNA fragmentation in their spermatozoa
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Punalpin | Dietary supplement | Punalpin |
| Placebo | Other | Placebo |
Primary outcome
Sperm DNA fragmentation
Time frame: 4 months
Reduction in DNA fragmentation
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 31 May 2022.
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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?
A study testing Punalpin in people with Infertility, Male, run by Odense University Hospital.
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: finished, as of the sponsor's last update on 31 May 2022. 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. Some participants in this study may receive a placebo. 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?
Sperm DNA fragmentation (time frame: 4 months). 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 31 May 2022.