NCT06202469

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 28, 2023

Last Update Submit

December 3, 2024

Conditions

OligospermiaSperm Count, Low

Outcome Measures

Primary Outcomes (1)

  • Sperm concentration

    Number of sperm per milliliter of semen

    Change from baseline sperm concentration at 8 weeks

Secondary Outcomes (4)

  • Total antioxidant capacity

    Change from baseline total antioxidant capacity at 8 weeks

  • Creatine kinase

    Change from baseline creatine kinase at 8 weeks

  • Creatine

    Change from baseline creatine at 8 weeks

  • The World Health Organisation-Five Well-Being Index (WHO-5)

    Change from baseline WHO-5 at 8 weeks

Study Arms (3)

Supplement 1

EXPERIMENTAL

Creatine monohydrate

Dietary Supplement: Supplement 1

Supplement 2

EXPERIMENTAL

Creatine monohydrate plus ubiquinol

Dietary Supplement: Supplement 2

Placebo

PLACEBO COMPARATOR

Inulin

Dietary Supplement: Placebo

Interventions

Supplement 1DIETARY_SUPPLEMENT

Creatine monohydrate (5 g/day)

Supplement 1
Supplement 2DIETARY_SUPPLEMENT

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

Supplement 2
PlaceboDIETARY_SUPPLEMENT

Placebo (inulin)

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Major chronic disease and acute injuries
  • History of dietary supplement use during the past 28 days
  • No consent to randomization
  • Participation in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (2)

  • 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.

    PMID: 35276945BACKGROUND

  • Nedeljkovic 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.

    PMID: 41052075DERIVED

MeSH Terms

Conditions

Oligospermia

Interventions

TARGET 1 dietary supplement

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Sergej Ostojic, MD, PhD

    University of Novi Sad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 11, 2024

Study Start

December 15, 2023

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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

Locations

SE(1)