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Effects of coenzyme Q10 (CoQ10) supplementation on semen quality and seminal oxidative stress of idiopathic oligoasthenoteratozoospermic (iOAT) infertile men
ISRCTN ISRCTN29954277
DOI 10.1186/ISRCTN29954277
ClinicalTrials.gov identifier
EudraCT number
Public title Effects of coenzyme Q10 (CoQ10) supplementation on semen quality and seminal oxidative stress of idiopathic oligoasthenoteratozoospermic (iOAT) infertile men
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
Acronym N/A
Serial number at source Avicenna Research Center Ref: 5405/20/28PY (registered on 28/ 01/2008)
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval Avicenna Ethics Committee, approved on 10/03/2008 (ref: 6191/51/28PY)
Study design Double-blind randomised placebo-controlled single-centre trial
Countries of recruitment Iran
Disease/condition/study domain Male infertility
Participants - 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
Participants - exclusion criteria Discontinuation in supplement usage.
Anticipated start date 01/10/2008
Anticipated end date 01/10/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60
Interventions 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
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
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
Sources of funding Iran University of Medical Sciences (Iran)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21399391
Contact name Dr  Mohammad Reza  Sadeghi
  Address Avicenna Research Institute (ARI)
Shahid Beheshti University
Chamran EXP Way
PO Box: 19615-1177
  City/town Tehran
  Zip/Postcode 19615
  Country Iran
  Email sadeghi@avicenna.ac.ir
Sponsor Iran University of Medical Sciences (Iran)
  Address Crossing of Sheikh Fazlolah and Chamran Highway
  City/town Tehran
  Zip/Postcode 14155
  Country Iran
  Email sadeghi@avicenna.ac.ir
  Sponsor website: http://www.iums.ac.ir/index.php?slc_lang=en&sid=1
Date applied 05/10/2008
Last edited 08/05/2012
Date ISRCTN assigned 03/12/2008
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