OligospermiaCRESPAQ10NCT06202469
Creatine and Ubiquinol for Sperm Quality
A study testing Supplement 1 and Supplement 2 in people with Oligospermia and Sperm Count, Low, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial summary
This randomized controlled double-blind parallel-group interventional trial explores the impact of 8-week creatine supplementation, with or without ubiquinol, on sperm quality biomarkers in normospermic and oligospermic men. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oligospermia, Sperm Count, Low
- What is being tested?
- Supplement 1 and Supplement 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Dec 2023to 30 Jun 2024
- 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 35 years
- Sperm quality test available (at least half will have low sperm quality)
- Informed consent
- Healthy BMI (18.5 - 24.9 kg/m2)
Who cannot join
- Major chronic disease and acute injuries
- History of dietary supplement use during the past 28 days
- No consent to randomization
- Participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of 8-week Creatine Supplementation With and Without Ubiquinol on Sperm Quality Biomarkers in Normospermic and Oligospermic Men
This randomized controlled double-blind parallel-group interventional trial explores the impact of 8-week creatine supplementation, with or without ubiquinol, on sperm quality biomarkers in normospermic and oligospermic men. It aims to determine potential enhancements in sperm health to provide insights into male fertility and reproductive health improvement strategies.
- Conditions
- Oligospermia, Sperm Count, Low
- Being tested
- Supplement 1, Supplement 2, Placebo
- Medical subject headings
- Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement 1Dietary supplement
Creatine monohydrate (5 g/day)
Supplement 2Dietary supplement
Creatine monohydrate (5 g/day) plus ubiquinol (200 mg/day)
PlaceboDietary supplement
Placebo (inulin)
| Study group | Role | What they receive |
|---|---|---|
| Supplement 1 | Experimental | Creatine monohydrate Receives: Dietary Supplement: Supplement 1 |
| Supplement 2 | Experimental | Creatine monohydrate plus ubiquinol Receives: Dietary Supplement: Supplement 2 |
| Placebo | Placebo comparator | Inulin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm concentration
Number of sperm per milliliter of semen
Measured: Change from baseline sperm concentration at 8 weeks
Secondary outcomes (4)
Total antioxidant capacity
Level of total antioxidant capacity in semen
Measured: Change from baseline total antioxidant capacity at 8 weeks
Creatine kinase
Level of creatine kinase in semen
Measured: Change from baseline creatine kinase at 8 weeks
Creatine
Level of creatine in semen
Measured: Change from baseline creatine at 8 weeks
The World Health Organisation-Five Well-Being Index (WHO-5)
The World Health Organisation-Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.The raw scores are transformed to a score from 0 to 100, with lower scores indicating worse well-being.
Measured: Change from baseline WHO-5 at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Dec 2023
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OligospermiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
- Investigators
- Sergej Ostojic, MD, PhD, Principal investigator, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202469
- Sponsor's protocol ID
- CR-24-AK15
- Acronym
- CRESPAQ10
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in sperm quality. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Publications
Ostojic SM, Stea TH, Engeset D. Creatine as a Promising Component of Paternal Preconception Diet. Nutrients. 2022 Jan 28;14(3):586. doi: 10.3390/nu14030586.
PubMed 35276945Nedeljkovic D, Todorovic N, Javorac D, Baltic S, Vranes M, Panic J, Kladar N, Ratgeber L, Betlehem J, Acs P, Stea TH, Engeset D, Stajer V, Ostojic SM. The effects of 8-week creatine supplementation with and without ubiquinol on sperm quality biomarkers in normospermic and oligospermic men: A randomized controlled pilot trial. Nutr Health. 2025 Oct 6:2601060251385000. doi: 10.1177/02601060251385000. Online ahead of print.
PubMed 41052075
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 8-week Creatine Supplementation With and Without Ubiquinol on Sperm Quality Biomarkers in Normospermic and Oligospermic Men
- ClinicalTrials.gov ID
- NCT06202469
- Acronym / sponsor ID
- CRESPAQ10 / CR-24-AK15
- Conditions
- Oligospermia, Sperm Count, Low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Jan 2024 (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.
This randomized controlled double-blind parallel-group interventional trial explores the impact of 8-week creatine supplementation, with or without ubiquinol, on sperm quality biomarkers in normospermic and oligospermic men. It aims to determine potential enhancements in sperm health to provide insights into male fertility and reproductive health improvement strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supplement 1 | Experimental | Dietary Supplement: Supplement 1Creatine monohydrate |
| Supplement 2 | Experimental | Dietary Supplement: Supplement 2Creatine monohydrate plus ubiquinol |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInulin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 - 35 years
- Sperm quality test available (at least half will have low sperm quality)
- Informed consent
- Healthy BMI (18.5 - 24.9 kg/m2)
Key exclusion criteria (4 listed)
- Major chronic disease and acute injuries
- History of dietary supplement use during the past 28 days
- No consent to randomization
- Participation in other studies
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 |
|---|---|---|
| Supplement 1Creatine monohydrate (5 g/day) | Dietary supplement | Supplement 1 |
| Supplement 2Creatine monohydrate (5 g/day) plus ubiquinol (200 mg/day) | Dietary supplement | Supplement 2 |
| PlaceboPlacebo (inulin) | Dietary supplement | Placebo |
Primary outcome
Sperm concentration
Time frame: Change from baseline sperm concentration at 8 weeks
Number of sperm per milliliter of semen
4 secondary outcomes
Total antioxidant capacity
Time frame: Change from baseline total antioxidant capacity at 8 weeks
Creatine kinase
Time frame: Change from baseline creatine kinase at 8 weeks
Creatine
Time frame: Change from baseline creatine at 8 weeks
The World Health Organisation-Five Well-Being Index (WHO-5)
Time frame: Change from baseline WHO-5 at 8 weeks
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 4 Dec 2024.
- Background: PubMed 35276945Ostojic SM, Stea TH, Engeset D. Creatine as a Promising Component of Paternal Preconception Diet. Nutrients. 2022 Jan 28;14(3):586. doi: 10.3390/nu14030586.
- Derived from this study: PubMed 41052075Nedeljkovic D, Todorovic N, Javorac D, Baltic S, Vranes M, Panic J, Kladar N, Ratgeber L, Betlehem J, Acs P, Stea TH, Engeset D, Stajer V, Ostojic SM. The effects of 8-week creatine supplementation with and without ubiquinol on sperm quality biomarkers in normospermic and oligospermic men: A randomized controlled pilot trial. Nutr Health. 2025 Oct 6:2601060251385000. doi: 10.1177/02601060251385000. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in sperm quality. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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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.
Sergej Ostojic, MD, PhD principal investigator
University of Novi Sad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement 1 and Supplement 2 in people with Oligospermia and Sperm Count, Low, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
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 4 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 4 Dec 2024. 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 Serbia. 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. 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 concentration (time frame: Change from baseline sperm concentration at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06202469, which also lists 2 linked publications.
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 4 Dec 2024; AzTrials last refreshed its copy on 1 Nov 2026.