Protocol summary

Study aim
Comparison of the effect of Nettle and Alyssum with Q10 plus and L-Carnitine on improving sperm parameters of infertile men referred to infertility clinic in Jahrom city, 2021.
Design
A randomized controlled clinical trial with parallel groups, three blinded, randomized
Settings and conduct
The researcher, after approving the project in the Research Council of Rafsanjan University of Medical Sciences and obtaining the code of ethics and obtaining the necessary authorization to conduct research, will refer to the infertility clinic in Jahrom city . Male infertility are screened for entry requirements and if eligible, explaining the purpose of the study, they are invited to participate in the project and they will enter the study with written consent. To the intervention group orthidine tablets 150 mg, 3 daily and extract of Qadoomeh, 2 capsules of 300 mg daily and The control group will be given KQ10 Plus 100 mg and L-carnitine 500 mg daily For 12 weeks. T the study will be three-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study and written consent, Living with a spouse, Spouse un infertility, Age 20 to 45 years, Disorder in at least one of the sperm parameters Infertility after 12 months of intercourse without using contraceptive methods,
Intervention groups
Intervention group: Intervention group: Taking orthidine tablets 150 mg, 3 daily and extract of Alyssum, 2 capsules of 300 mg daily and Control group: Qu10 Plus 100 mg tablets and L-carnitine 500 mg tablets daily For 12 weeks
Main outcome variables
Status of spermogram parameters, before and 12 weeks after the start of the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160308026971N12
Registration date: 2021-07-30, 1400/05/08
Registration timing: registered_while_recruiting

Last update: 2021-07-30, 1400/05/08
Update count: 0
Registration date
2021-07-30, 1400/05/08
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Nettle and Alyssum with Q10 plus and L-Carnitine on improving sperm parameters of infertile men referred to infertility clinic
Public title
Investigating the effect of Nettle and Alyssum with Q10 plus and L-Carnitine on improving sperm parameters of infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and written consent Living with a spouse Iranian nationality Age 20 to 45 years Disorder in at least one of the sperm parameters (At least 20 million sperm per milliliter of semen, 50% progressive motion And 4% of normal morphology) Infertility after 12 months of intercourse without using contraceptive methods
Exclusion criteria:
Spouse infertility Autoimmune diseases and chronic diseases that are known to affect fertility, such as cardiovascular disease, diabetes, hypertension Alcohol, cigarette and drug addiction Mental illness Severe marital conflicts History of radiation therapy and various cancers History of previous or current genitourinary tract diseases such as varicocele
Age
From 20 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use a random number table to assign infertile men to the control and intervention groups. The table of random numbers consists of random digits 0 to 9 And each of the digits in this table is repeated the same on average And there is no pattern of recognizable numbers. We make a random list using the random digits in the table, assigning each digit to a therapeutic appointment. Now for the two treatments, we assign the numbers 4-0 for treatment A and the numbers 5-9 for treatment B. We start the list at an optional point in the table that we have chosen at random. For example, if we start from the top row of the random number table randomly and optionally and And from left to right of the table and then move to the bottom rows, they create a list Which begins with the following treatments. We will continue to do this until our sample is complete.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The meaning of the three blinds is that the participants (people qualified to enter the project)، Assessor (the person who is to complete the relevant checklist before and 12 weeks after treatment) And Data Analyzer (Statistics Specialist) Unaware of which group (intervention or control) the information received and statistical data belong to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
No. 33, Alley 41, Mostafa Khomeini St
City
Rafsanjan
Province
Kerman
Postal code
7714668168
Approval date
2021-06-26, 1400/04/05
Ethics committee reference number
IR.RUMS.REC.1400.054

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 parameters in infertile men
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
The checklist consists of two parts: the first part is the demographic characteristics and the second part is the spermogram parameters

Secondary outcomes

1

Description
Number of sperm
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
The checklist consists of two parts: the first part is the demographic characteristics and the second part is the spermogram parameters

2

Description
Sperm motility
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
The checklist consists of two parts: the first part is the demographic characteristics and the second part is the spermogram parameters

3

Description
Sperm morphology
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
The checklist consists of two parts: the first part is the demographic characteristics and the second part is the spermogram parameters

Intervention groups

1

Description
Intervention group: Intervention group: Taking orthidine tablets (nettle) 150 mg, Made by Barij Essence Pharmaceutical Company 3 daily (7 am, 13 and 19 pm) and aqueous extract of Qadoomeh, 2 capsules of 300 mg daily (9 am and 9 pm) Which will be made by the Faculty of Pharmacy of Kerman University of Medical Sciences، For 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Control group: Qu10 Plus 100 mg tablets daily (9 am) Made by the German pharmaceutical company Eurovital and L-carnitine 500 mg tablets daily (9 pm) Made by Karen Iran Pharmaceutical Company For 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahrom Infertility Clinic
Full name of responsible person
Mahnaz kargar jahromi
Street address
22 Bahman Street, in front of the governor's office
City
Jahrom
Province
Fars
Postal code
7413634964
Phone
+98 71 5422 1040
Email
kargarmahnaz1372@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alo Shamsizadeh
Street address
Central Organization of Rafsanjan University of Medical Sciences and Health Services, Deputy of research and technology, Imam Ali Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
alishamsy@gmail.com
Web page address
http://vcrt.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com

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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