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Effect of Ubiquinone Supplementation on Semen Quality, Antioxidant Enzyme, Oxidative Stress and DNA Fragmentation in infertile men

Protocol summary

Summary
The present study was designed to determine the effects of CoQ10 supplementation on semen quality, seminal antioxidant enzymes, oxidative stress, and sperm DNA fragmentation in idiopathic oligoasthenoteratozospermic men referring to Avicenna infertility Clinic. In a randomized placebo-controlled trial, 60 infertile men aged between 20-50 years with idiopathic oligoasthenoteratozoosperia and at least 1 year history of infertility selected. They were excluded if they had infectious genital disease, anatomic abnormality of genital tract, occupational chemical exposure, history of genital tract surgery, or they used drug and antioxidant supplement within the 3 months before enrollment in the present study. The enrolled patients underwent dietary implementation of CoQ10 100 mg twice daily (200 mg) or placebo For 3 months. Seminal plasma superoxide dismutase, Glutathione peroxidase, and Glutathione reductase, TAC, Level of Isoprostane, Sperm DNA fragmentation and Ubiquinone concentration were assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138706031079N1
Registration date: 2011-08-09, 1390/05/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-08-09, 1390/05/18
Registrant information
Name
Mohammad Reza Sadeghi
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2024
Email address
sadeghi@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Research Institute, Tehran medical sciences university
Expected recruitment start date
2008-07-31, 1387/05/10
Expected recruitment end date
2009-08-01, 1388/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ubiquinone Supplementation on Semen Quality, Antioxidant Enzyme, Oxidative Stress and DNA Fragmentation in infertile men
Public title
Co Q10 and Semen parameter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion : idiopathic oligoasthenoteratospermia, normal profile for hormones, normal genital anatomy Exclusion: major infection in genital organ, treatment for systemic disease during the last three months of inclusion, surgery background on genitalia, exposure to chemicals ,solvents or heavy metals, supplementation therapy in last three months of inclusion
Age
From 20 years old to 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Avicenna Research Institute
Street address
Avicenna Research Institute, Shahid Beheshti University , Evin, Tehran
City
Tehran
Postal code
1983969411
Approval date
2008-09-03, 1387/06/13
Ethics committee reference number
87.3003

Health conditions studied

1

Description of health condition studied
Male Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
semen analysis
Timepoint
45 days , 90days
Method of measurement
HPLC, flourometry , spectrophotometry, ELIZA

2

Description
sperm Isoprostan concentration
Timepoint
45 days , 90days
Method of measurement
ELIZA

3

Description
activity of seminal plasma catalase
Timepoint
45 days , 90days
Method of measurement
spectrophotometry

4

Description
activity of seminal plasma superoxide dysmutase
Timepoint
45 days , 90days
Method of measurement
spectrophotometry

5

Description
seminal plasma ubiquinone concentration
Timepoint
45 days , 90days
Method of measurement
HPLC

6

Description
DNA fregmentation
Timepoint
45 days , 90days
Method of measurement
Flowcytometry

Secondary outcomes

1

Description
seminal plasma gluthation peroxidase
Timepoint
45 days, 90 days
Method of measurement
spectrophotometry

2

Description
seminal plasma gluthation reductase
Timepoint
45 days, 90 days
Method of measurement
spectrophotometry

3

Description
Total Antioxidant Capacity(TAC)
Timepoint
45 days, 90 days
Method of measurement
spectrophotometry

4

Description
seminal plasma Coenzyme Q10
Timepoint
45 days, 90 days
Method of measurement
HPLC

Intervention groups

1

Description
Co Q10 supplement: 2 (100 mg) per day (200 mg), 3 month,
Category
Treatment - Drugs

2

Description
Placebo (lactose): 2 capsule per day, 3 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Avicenna Infertility Clinic
Full name of responsible person
Mohammad Reza Sadeghi
Street address
No 97, Yakhchal and Shariati Ave Cross, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Avicenna Research Institute; Tehran Medical Sciences University
Full name of responsible person
Mohammad Reza Sadeghi
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin, Tehran; Tehran Medical Science University, Crossing of Chamran and Hemmat highways, Tehran
City
Tehran
Grant name
113641
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Research Institute; Tehran Medical Sciences University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Avicenna Resaerch Institute
Full name of responsible person
Mohammad Reza Sadeghi
Position
Associate professor / Ph.D.
Other areas of specialty/work
Street address
Avicenna Research Institute, Shahid Beheshti University , Evin, Tehran
City
Tehran
Postal code
1983969411
Phone
+98 21 2243 2024
Fax
+98 21 2243 2021
Email
sadeghi@avicenna.ac.ir
Web page address
www.avicenna.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Mohammad Reza Sadeghi
Position
Associate Professor / Ph.D.
Other areas of specialty/work
Street address
Avicenna Research Institute, Shahid Beheshti University , Evin
City
Tehran
Postal code
1983969411
Phone
+98 21 2243 2024
Fax
+98 21 2243 2021
Email
sadeghi@avicenna.ac.ir
Web page address
www.avicenna.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Mohammad Reza sadeghi
Position
Associate professor / Ph.D.
Other areas of specialty/work
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin, Tehran.
City
Tehran
Postal code
1983969411
Phone
+98 21 2243 2024
Fax
+98 21 2243 2021
Email
sadeghi@avicenna.ac.ir
Web page address
www.avicenna.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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