ClinicalTrials.gg
CompletedNCT06202469CRESPAQ10Updated Dec 4, 2024

Creatine and Ubiquinol for Sperm Quality

An interventional study of Supplement 1 and Supplement 2 in Oligospermia and Sperm Count, Low, sponsored by University of Novi Sad, Faculty of Sport and Physical Education. Completed at 1 site in Serbia. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by University of Novi Sad, Faculty of Sport and Physical Education · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
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Study 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. It aims to determine potential enhancements in sperm health to provide insights into male fertility and reproductive health improvement strategies.

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Conditions studied

  • Oligospermia
  • Sperm Count, Low

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03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's enrollment of 18 is below the median of 65 across 46 interventional studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 - 35 years
  • Sperm quality test available (at least half will have low sperm quality)
  • Healthy (18.5 - 24.9 kg/m2)

Exclusion criteria

Exclusion Criteria:

  • Major chronic disease and acute injuries
  • History of dietary supplement use during the past 28 days
  • No consent to randomization
  • Participation in other studies
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Supplement 1

    Creatine monohydrate

    Dietary Supplement: Supplement 1

  • Experimental
    Supplement 2

    Creatine monohydrate plus ubiquinol

    Dietary Supplement: Supplement 2

  • Placebo comparator
    Placebo

    Inulin

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementSupplement 1

    Creatine monohydrate (5 g/day)

  • Dietary supplementSupplement 2

    Creatine monohydrate (5 g/day) plus ubiquinol (200 mg/day)

  • Dietary supplementPlacebo

    Placebo (inulin)

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What researchers measure

Primary outcomes

  1. Sperm concentration

    Number of sperm per milliliter of semen

    Time frame: Change from baseline sperm concentration at 8 weeks

Secondary outcomes

  1. Total antioxidant capacity

    Level of total antioxidant capacity in semen

    Time frame: Change from baseline total antioxidant capacity at 8 weeks

  2. Creatine kinase

    Level of creatine kinase in semen

    Time frame: Change from baseline creatine kinase at 8 weeks

  3. Creatine

    Level of creatine in semen

    Time frame: Change from baseline creatine at 8 weeks

  4. 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.

    Time frame: Change from baseline WHO-5 at 8 weeks

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Study locations

1 site
  • FSPE Applied Bioenergetics Lab
    Novi Sad, Vojvodina 21000, Serbia
08

References and documents

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 35276945 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

Access criteria: Only qualified researchers with academic interest in sperm quality

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06202469
Lead sponsor
University of Novi Sad, Faculty of Sport and Physical Education
Responsible party
Sergej Ostojic (Professor, University of Novi Sad, Faculty of Sport and Physical Education) — Principal investigator
First posted
Jan 11, 2024
Start date
Dec 15, 2023
Primary completion
May 31, 2024
Completion
Jun 30, 2024
Last update
Dec 4, 2024

Study contacts

Sergej Ostojic, MD, PhD
principal investigator · University of Novi Sad

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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