-Evaluation of the effect of myoinositol on sperm movement in oligoastenospermia؛
-Evaluation the effect of myoinositol on sperm DNA fragmentation in oligoastenospermia؛
-evaluation of the effect of myoinositol on sperm morphology in oligoastenospermia؛
-Evaluation of the effect of myoinositol on fertility in oligoastenospermia.
Design
Two groups of patients with inositol and non-inositol
triple blind randomized Clinical trial
Settings and conduct
for IUI Treatment Semen sample removed after 48-72h from the ejaculation method and then placed in a 37-degree incubator for 30 minutes. After liquefying the sample, the sperm analysis with gradient method (sill select plus)After the sperm separation step, the subjects were randomly divided into two groups of 30, after examining the spermatic parameters, the parameters were examined and recorded.
Patient, physician and responsible for evaluation of sperm parameters, did not know the type of sample
at the IVF center in Shahid Akbar Abadi Hospital
Participants/Inclusion and exclusion criteria
inclusion criteria:
-Couples who have not been pregnant for one year؛
-hysterosalpingography and hormonal testing of all women were uncomplicated؛
-men have oligo or asthenospermia.
Exclusion criteria:
1- Sever male factor (male Oligo Stato )
2. Untreated hormonal problem
3. BMI higher than 35
4. Age of a woman older than 38 years
Intervention groups
In the first group: no intervention was performed and the sperms were incubated for 2 hours at 37 ° C In the .5 ml medium, the medium of flushing is encapsulated in the kit.
To the second group: two milliliters of myoinositol are added and incubated for 37 ° C in the incubator for 2 hours.
Main outcome variables
-Number of live sperm (viability)؛
-Sperm motility؛
-Morphology؛
-Agglutination؛
-Volume؛
-Acidity؛
-Duration of liquefaction؛
-Dfi؛
-Fertility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181031041519N1
Registration date:2019-01-06, 1397/10/16
Registration timing:retrospective
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Seyyedeh Tahere Ghazimirsaeed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 8831
Email address
ghazimirsaeed.st@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-03-20, 1395/12/30
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
2018-03-20, 1396/12/29
Scientific title
Effect of Myo-inositol on Sperm Parameters and Fertility Rate in Patients with Oligoasthenospermia Treated with IUI: A Randomized Clinical Trial
Public title
The effect of Myo-inositol on the treatment of male infertility in couples under IUI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Couples who have not been pregnant for one year
In the studies included hysterosalpingography and hormonal testing all women were uncomplicated
Men have oligo or asthenospermia.
Exclusion criteria:
Sever male factor (Oligo Stoenou men)
Untreated hormonal problem
BMI higher than 35
The age of a woman is over 38 years old
Age
To 38 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
- Patients were randomly divided into two groups using Excel software
- We used stratified randomization
- Each code contained in sealed envelopes was provided to clinical care
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients are divided into two groups of case and control according to the random numbers table, and patient, the physician and responsible for examining the sperm parameters didnt know which sample containing or not containing inositol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences.Hemmat Ave.Tehran Town
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.IUMS.FMD.REC1396.9211290014
Health conditions studied
1
Description of health condition studied
Male infertility due to oligoastenospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Sperm motility Morphology Agglutination Volume Acidity Duration of liquefaction Dfi
Timepoint
sperm sample day After sample incubation Two hours after treatment with myo-inositol
Method of measurement
Examination of sperm samples under a microscope
Secondary outcomes
1
Description
Fertility
Timepoint
Two weeks after iui
Method of measurement
Serum Beta HCG
Intervention groups
1
Description
Semen sample removed after 48-72h from the ejaculation method and then placed in a 37-degree incubator for 30 minutes. After liquefying the sample, the sperm analysis with gradient method (sill select plus)After the sperm separation step, the subjects were randomly divided into two groups. Intervention Group: in the semen of this group, add .5 milliliter of myoinositol at a concentration of 2 mg/ml and incubate for 37 °C in the incubator for 2 hours.
Category
Treatment - Drugs
2
Description
Control group: Semen sample removed after 48-72h from the ejaculation method and then placed in a 37-degree incubator for 30 minutes. After liquefying the sample, the sperm analysis with gradient method (sill select plus)After the sperm separation step, the subjects were randomly divided into two groups. Control Group: in the semen of this group not add myoinositol, but only incubate for 37 °C in the incubator for 2 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital, IVF Center
Full name of responsible person
Seyyedeh Tahereh ghazimirsaeed
Street address
shahid akbar abadi Hospital.molavi St.Tehran
City
tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Web page address
http://crta.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakoti
Street address
Iran, Tehran, Hemat Highway, Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2553
Fax
+98 21 8670 2553
Email
PR@iums.ac.ir
Web page address
http://vcr.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyyedeh Tahereh Ghazi mirsaeed
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
no8.colop 18 Ally.imam montazer St.Satarkhan St
City
tehran
Province
Tehran
Postal code
1444933611
Phone
+98 21 8826 5089
Email
dr.ghazi83@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
dr.zahra doroodian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasul akram Hospital Satarkhan St
City
tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 9595
Email
dr.ghazi83@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyedeh tahereh ghazimirsaeed
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
no8.colop18Ally.imam montazer St
City
tehran
Province
Tehran
Postal code
4933611144
Phone
+98 21 8826 5089
Email
dr.ghazi83@gmail.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