Condition category
Urological and Genital Diseases
Date applied
05/10/2008
Date assigned
03/12/2008
Last edited
08/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohammad Reza Sadeghi

ORCID ID

Contact details

Avicenna Research Institute (ARI)
Shahid Beheshti University
Chamran EXP Way
PO Box: 19615-1177
Tehran
19615
Iran
sadeghi@avicenna.ac.ir

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Avicenna Research Center Ref: 5405/20/28PY (registered on 28/ 01/2008)

Study information

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

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

Ethics approval

Avicenna Ethics Committee, approved on 10/03/2008 (ref: 6191/51/28PY)

Study design

Double-blind randomised placebo-controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Ubiquinone (coenzyme Q10)

Primary outcome measures

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 trial start date

01/10/2008

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

60

Participant exclusion criteria

Discontinuation in supplement usage.

Recruitment start date

01/10/2008

Recruitment end date

01/10/2009

Locations

Countries of recruitment

Iran

Trial participating centre

Avicenna Research Institute (ARI)
Tehran
19615
Iran

Sponsor information

Organisation

Iran University of Medical Sciences (Iran)

Sponsor details

Crossing of Sheikh Fazlolah and Chamran Highway
Tehran
14155
Iran
sadeghi@avicenna.ac.ir

Sponsor type

University/education

Website

http://www.iums.ac.ir/index.php?slc_lang=en&sid=1

Funders

Funder type

University/education

Funder name

Iran University of Medical Sciences (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21399391

Publication citations

  1. Results

    Nadjarzadeh A, Sadeghi MR, Amirjannati N, Vafa MR, Motevalian SA, Gohari MR, Akhondi MA, Yavari P, Shidfar F, Coenzyme Q10 improves seminal oxidative defense but does not affect on semen parameters in idiopathic oligoasthenoteratozoospermia: a randomized double-blind, placebo controlled trial., J. Endocrinol. Invest., 2011, 34, 8, e224-8, doi: 10.3275/7572.

Additional files

Editorial Notes