Observe Effect of Antioxidant on Sperm DNA FragmentionNCT03646825
Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation
An observational study of Observe Effect of Antioxidant on Sperm DNA Fragmention, run by Colorado Center for Reproductive Medicine at 1 site in United States.
Trial summary
Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Observe Effect of Antioxidant on Sperm DNA Fragmention
- What is being tested?
- Natural Antioxidant supplement
- Type of treatment
- Pill or oral medicine
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Oct 2022
- 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 55 years
- Men only
- Adult
Study population: Male patients pursuing IVF for treatment of infertility
Who may be able to join
- -Sperm Chromatin >16%, sufficient ejaculate sperm for ICSI
Who cannot join
- Severe male factor infertility
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124
About this study
Official title: Observation Study of the Effect of Use of Natural Antioxidant Supplement on Sperm DNA Fragmentation
Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing.
Read the detailed description
Male patients will be recruited based on having a high DNA fragmentation (chromatin >16) no other severe male factor infertility (>5million/ml, count, > 10%motility and >1% morphology) and sufficient ejaculate sperm for ICSI (no surgically removed sperm or history of vasectomy reversal). Patients will be provided the natural antioxidant supplementation by the sponsor. Patients will take 1 capsule orally 3 times a day for a full 12 weeks. Sperm DNA structure will be re-assessed after completion of 12 weeks of antioxidant to compare to baseline sperm DNA structure collected prior to starting regimen of supplement daily
- Being tested
- Natural Antioxidant supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Antioxidant supplementDietary supplement
1 capsule orally three times a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Male patients exposed to antioxidant for 12 weeks Receives: Dietary Supplement: Natural Antioxidant supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm DNA fragmentation
Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Aug 2018
- Primary completion15 Jun 2022
- Study completion1 Oct 2022
Why it stopped: Completed study with fewer participants than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observe Effect of Antioxidant on Sperm DNA FragmentionStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Makloski, Study chair, Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646825
- Sponsor's protocol ID
- 20170532
- Status last verified
- Feb 2023
- First submitted
- 23 Aug 2018
- Last updated
- 23 Feb 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 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Study of the Effect of Use of Natural Antioxidant Supplement on Sperm DNA Fragmentation
- ClinicalTrials.gov ID
- NCT03646825
- Acronym / sponsor ID
- 20170532
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Completed study with fewer participants than expected
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Colorado Center for Reproductive MedicineUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 24 Aug 2018 (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.
Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing.
Detailed description
Male patients will be recruited based on having a high DNA fragmentation (chromatin >16) no other severe male factor infertility (>5million/ml, count, > 10%motility and >1% morphology) and sufficient ejaculate sperm for ICSI (no surgically removed sperm or history of vasectomy reversal). Patients will be provided the natural antioxidant supplementation by the sponsor. Patients will take 1 capsule orally 3 times a day for a full 12 weeks. Sperm DNA structure will be re-assessed after completion of 12 weeks of antioxidant to compare to baseline sperm DNA structure collected prior to starting regimen of supplement daily
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Dietary Supplement: Natural Antioxidant supplementMale patients exposed to antioxidant for 12 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Male patients pursuing IVF for treatment of infertility
Key inclusion criteria (1 listed)
- -Sperm Chromatin >16%, sufficient ejaculate sperm for ICSI
Key exclusion criteria (1 listed)
- Severe male factor infertility
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 |
|---|---|---|
| Natural Antioxidant supplement1 capsule orally three times a day for 12 weeks | Dietary supplement | Treatment group |
Primary outcome
Sperm DNA fragmentation
Time frame: 12 weeks
Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure
Results and safety
The study was stopped early (reason given: Completed study with fewer participants than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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.
Rachel Makloski study chair
Study Coordinator
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 Observe Effect of Antioxidant on Sperm DNA Fragmention, run by Colorado Center for Reproductive Medicine at 1 site in United States.
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: stopped early, as of the sponsor's last update on 23 Feb 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 United States. 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?
The study was stopped early (reason given: Completed study with fewer participants than expected). Results are not available in the source record.
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: 12 weeks). 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 23 Feb 2023.