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 |
| Secondary identifying numbers | Avicenna Research Center Ref: 5405/20/28PY (registered on 28/ 01/2008) |
- 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
Scientific
Avicenna Research Institute (ARI)
Shahid Beheshti University
Chamran EXP Way
PO Box: 19615-1177
Tehran
19615
Iran
| sadeghi@avicenna.ac.ir |
Study information
| Study design | Double-blind randomised placebo-controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ubiquinone (coenzyme Q10) |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/10/2008 |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 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
19615
Iran
Sponsor information
Iran University of Medical Sciences (Iran)
University/education
University/education
Crossing of Sheikh Fazlolah and Chamran Highway
Tehran
14155
Iran
| sadeghi@avicenna.ac.ir | |
| Website | http://www.iums.ac.ir/index.php?slc_lang=en&sid=1 |
"ROR" |
https://ror.org/03w04rv71 |
Funders
Funder type
University/education
Iran University of Medical Sciences (Iran)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
