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Effect of CO-Q 10 supplementation versus placebo on spermogram parameters and sexual function in infertile men: a double-blind randomized clinical trial

Protocol summary

Study aim
To assess the effect of CO-Q 10 supplementation versus placebo on spermogram parameters and sexual function in infertile men
Design
This is a double-blind randomized clinical trial, phase II, in which 70 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible men with primary infertility who will refer to Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 40 years; Man with primary infertility; Abnormality in at least one of the sperm parameters; Body mass index less than 30. Exclusion criteria: Chromosomal abnormalities; Varicocele; Cryptorchidism; Chronic diseases such as diabetes, kidney disease, infectious diseases, genital tract infection, thyroid disorder; Drug or alcohol use; Taking spermatogenic drugs; Taking pituitary suppressive drugs; Taking anti-androgens; Taking alpha-blockers, antidepressants, or phenothiazide; History of testis surgery.
Intervention groups
Intervention group: Routine infertility treatment plus Q10 coenzyme capsule (CO-Q 10) (manufactured by Nature Mid Pharmaceuticals) 30 mg daily for 12 weeks Control group: Routine infertility treatment plus placebo capsule (manufactured by the Laboratory of School of Pharmacy, Hamadan University of Medical Sciences) once daily for 12 weeks
Main outcome variables
Primary outcome: Sperm volume; sperm count; sperm concentration; sperm motility; sperm morphology

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N322
Registration date: 2019-12-16, 1398/09/25
Registration timing: prospective

Last update: 2019-12-16, 1398/09/25
Update count: 0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of CO-Q 10 supplementation versus placebo on spermogram parameters and sexual function in infertile men: a double-blind randomized clinical trial
Public title
Effect of CO-Q 10 supplementation spermogram parameters and sexual function in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years, Man with primary infertility, Abnormality in at least one of the sperm parameters (volume, concentration, number, motility, or morphology), Body mass index less than 30,
Exclusion criteria:
Chromosomal abnormalities, Varicocele, Cryptorchidism, Chronic diseases such as diabetes, kidney disease, infectious diseases, genital tract infection, thyroid disorder, Drug or alcohol use, Taking spermatogenic drugs (methotrexate, nitrofurantoin, colchicine or chemotherapy), Taking pituitary suppressive drugs (testosterone, GnRh analogs), Taking anti-androgens (cimetidine or spironolactone), Taking alpha-blockers, antidepressants, or phenothiazide, History of testis surgery
Age
From 15 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.UMSHA.REC.1398.729

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
Sperm volume
Timepoint
Before and 12 weeks after the intervention
Method of measurement
By spermogram analysis

2

Description
Sperm count
Timepoint
Before and 12 weeks after the intervention
Method of measurement
By spermogram analysis

3

Description
Sperm concentration
Timepoint
Before and 12 weeks after the intervention
Method of measurement
By spermogram analysis

4

Description
Sperm motility
Timepoint
Before and 12 weeks after the intervention
Method of measurement
By spermogram analysis

5

Description
Sperm morphology
Timepoint
Before and 12 weeks after the intervention
Method of measurement
By spermogram analysis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Routine infertility treatment plus Q10 coenzyme capsule (CO-Q 10) (manufactured by Nature Mid Pharmaceuticals) 30 mg daily for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Routine infertility treatment plus placebo capsule (manufactured by the Laboratory of School of Pharmacy, Hamadan University of Medical Sciences) once daily for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Taiebeh Gharakhani
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
tabahar6@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Taiebeh Gharakhani
Position
Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
tabahar6@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Zahra Massomi
Position
Fertility Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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