Effects of coenzyme Q10 (CoQ10) supplementation on semen quality and seminal oxidative stress of idiopathic oligoasthenoteratozoospermic (iOAT) infertile men

ISRCTN	ISRCTN29954277
DOI	https://doi.org/10.1186/ISRCTN29954277
Protocol serial number	Avicenna Research Center Ref: 5405/20/28PY (registered on 28/ 01/2008)
Sponsor	Iran University of Medical Sciences (Iran)
Funder	Iran University of Medical Sciences (Iran)

Submission date: 05/10/2008
Registration date: 03/12/2008
Last edited: 08/05/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mohammad Reza Sadeghi
Scientific

Avicenna Research Institute (ARI)
Shahid Beheshti University
Chamran EXP Way
PO Box: 19615-1177
Tehran
19615
Iran

Email	sadeghi@avicenna.ac.ir

Study information

Primary study design	Interventional
Study design	Double-blind randomised placebo-controlled single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of three-month supplementation with 200 mg of ubiquinone (coenzyme Q10 [CoQ10]) on semen quality, antioxidant enzymes of seminal plasma, sperm DNA fragmentation, total antioxidant capacity and isoprostane of seminal plasma in idiopathic oligoasthenoteratozoospermic infertile men: a double-blind randomised placebo-controlled trial
Study objectives	The ubiquinone supplementation will: 1. Increase sperm motility 2. Increase the percent of normal sperms 3. Increase curvilinear velocity of sperm 4. Increase straight progressive velocity of sperm 5. Decrease 15-2 alpha isoprostane in seminal plasma 6. Increase total antioxidant capacity of seminal plasma 7. Decrease sperm DNA fragmentation 8. Increase catalase activity in seminal plasma 9. Increase super oxide dismutase activity in seminal plasma 10. Increase glutathione peroxidase activity in seminal plasma 11. Increase ubiquinone concentration in seminal plasma
Ethics approval(s)	Avicenna Ethics Committee, approved on 10/03/2008 (ref: 6191/51/28PY)
Health condition(s) or problem(s) studied	Male infertility
Intervention	The participants will be randomly allocated to the following two arms (randomisation ratio 1:1): Intervention group: 100 mg ubiquinone capsule (oral) (Pharmed Int. Inc., Canada) twice daily with lunch and dinner for 3 months Control group: Placebo (lactose powder) in similar capsules twice daily for 3 months Total duration of follow-up: 90 days
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ubiquinone (coenzyme Q10)
Primary outcome measure(s)	1. Super oxide dismutase and glutathione peroxidase activity of seminal plasma and 15-F2 alpha isoprostane concentration will be measured by commercial kits 2. Catalase activity of seminal plasma 3. Total antioxidant capacity of seminal plasma 4. Concentration of ubiquionone in seminal plasma will be measured by High Performance Liquid Chromatography (HPLC) at baseline and 3 months 5. Dietary intake will be assessed by 3 days dietary recall at baseline, 45 days and 3 months and will be analysed by nutrition analysis software (Food Processor II) All primary outcomes will be assessed at baseline and 3 months
Key secondary outcome measure(s)	1. Sperm morphology and motility will be assessed with spermiogeram in accordance with the WHO 1999 criteria and also by computer-assisted sperm analysis 2. Sperm DNA fragmentation will be measured by Sperm Chromatin Structure Analysis (SCSA) All secondary outcomes will be assessed at baseline and 3 months
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	60
Key inclusion criteria	1. Men 20-45 years 2. With idiopathic oligoasthenoteratozoospermia (sperm count 5-20 x 10^6/mL ,sperm motility according to World Health Organization (WHO) 1999 criteria <50% and normal sperm morphology <30%) 3. Seminal white blood cells <1 x 10^6/mL 4. At least 1 year of infertility 5. Normal serum levels of gonadotropines, testosterone and prolactine 6. Absence of systemic diseases, treatment with drug or supplement use in the 3 months before enrolment 7. Absence of infectious genital disease and anatomical abnormalities of the genital tract 8. Absence of smoking, drug addiction or alcohol consumption 9. Absence of occupational chemical exposure 10. Absence of surgical history on testis or vasodeferane
Key exclusion criteria	Discontinuation in supplement usage.
Date of first enrolment	01/10/2008
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

Iran

Study participating centre

Avicenna Research Institute (ARI)

Tehran
19615
Iran

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes