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The effect of myo-inositol and N-acetyl-L-cysteine on improving of the quantitative and qualitative indices of prepared sperms for using in Assisted Reproductive Technology (IVF/ICSI)

Protocol summary

Study aim
determination of the effect of myo-inositol and N-acetyl-L-cysteine on improving of the quantitative and qualitative indices of prepared sperms for using in Assisted Reproductive Technology (IVF/ICSI)
Design
This study is a clinical trial with a control group, parallel groups, No Blind and No Randomization.
Settings and conduct
This study was performed on 63 infertile patients due to male factors referred to Hazrat Zahra infertility treatment center in Shahrekord.After semen sampling and preparation, before and after the intervention, all of the sperm biological parameters as well as all the sperm fertility indexes using Makler lam(Contrast phase microscope) and SQA-V gold version 2.48 sperm analyzer were examined by one person (Andrology expert) and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Infertility history for at least 12 months, Infertility with male causes ,Non-use of minerals, multivitamins and any fertility enhancer drug during the last three months Exclusion criteria:Using alcoholic drinks or Unauthorized compounds and drugs(Opiate, Psychotropic drugs, Bodybuilding compounds, Antipsychotics, Sedative)
Intervention groups
The prepared sperm sample is divided into four parts: Treatment group1 : One portion of the sample is incubated with myo-inositol drug(INOFOLIC Sachet, Parsian health) at a concentration of 2 mg / ml at 37 ° C for 20 minutes. Treatment group2 : One portion of the sample is incubated with NAC Antioxidant drug( 600 mg Sachet, Iran daro) for 20 minutes. Treatment group 3 : One portion of the sample is incubated with myovinitsil + NAC for 20 minutes. Control group: The final portion of the sample is incubated without any drug for 20 minutes at 37 ° C.
Main outcome variables
Sperm viability, sperm morphology, total sperm motility,SMI, PMSCa ,PMSCb

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190204042618N2
Registration date: 2019-03-26, 1398/01/06
Registration timing: registered_while_recruiting

Last update: 2019-03-26, 1398/01/06
Update count: 0
Registration date
2019-03-26, 1398/01/06
Registrant information
Name
najme bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 8235
Email address
st_bagherin@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of myo-inositol and N-acetyl-L-cysteine on improving of the quantitative and qualitative indices of prepared sperms for using in Assisted Reproductive Technology (IVF/ICSI)
Public title
The effect of myo-inositol and N-acetyl-L-cysteine on prepared sperms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility history for at least 12 months Infertility with male causes Non-use of minerals, multivitamins and any fertility enhancer drug during the last three months
Exclusion criteria:
Using alcoholic drinks or Unauthorized compounds and drugs(Opiate, Psychotropic drugs, Bodybuilding compounds, Antipsychotics, Sedative)
Age
From 18 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 63
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.SKUMS.REC.1396.190

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 viability
Timepoint
Before the proximity to medication, at the end of the incubation period
Method of measurement
Trypan blue staining and contrast phase microscope

2

Description
Sperm morphology
Timepoint
Before the proximity to medication, at the end of the incubation period
Method of measurement
Contrast phase microscope, Sperm analyzer device

3

Description
total sperm motility
Timepoint
Before the proximity to medication, at the end of the incubation period
Method of measurement
Contrast phase microscope, Sperm analyzer device

4

Description
SMI
Timepoint
Before the proximity to medication, at the end of the incubation period
Method of measurement
Sperm analyzer device

5

Description
PMSCa
Timepoint
Before the proximity to medication, at the end of the incubation period
Method of measurement
Contrast phase microscope, Sperm analyzer device

6

Description
PMSCb
Timepoint
Before the proximity to medication, at the end of the incubation period
Method of measurement
Contrast phase microscope, Sperm analyzer device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: is incubated with myo-inositol drug(INOFOLIC Sachet, Parsian health) at a concentration of 2 mg / ml at 37 ° C for 20 minutes
Category
Treatment - Drugs

2

Description
Intervention group: is incubated with NAC( 600 mg Sachet, Iran daro)Antioxidant drug at 37 ° C for 20 minutes.
Category
Treatment - Drugs

3

Description
Intervention group: is incubated withmyovinitsil + NAC at 37 ° C for 20 minutes.
Category
Treatment - Drugs

4

Description
Control group: is incubated without any drug for 20 minutes at 37 ° C.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord Hazrat Zahra Infertility Center
Full name of responsible person
Maryam Nemati
Street address
Infertility Center of Hazrat Zahra, Next to the Imam Hassan mosque, West Saadi Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816866659
Phone
+98 38 3222 0478
Email
mertanem@yahoo.co.uk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Seyed Kamal Solati
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Nemati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 8235
Email
nemati.m2016@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Nemati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 8235
Email
nemati.m2016@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Nemati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 8235
Email
nemati.m2016@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
data will be kept private.
Study Protocol
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Useing data to complete studies
From where data/document is obtainable
Shahre-kord University of Medical Sciences, Dr Maryam Nemati
What processes are involved for a request to access data/document
after delibration of researcher request and presentation of adequate documents,it will be able to exhibite.
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