Assessment and comparison of sperm apoptosis, embryo cytokinetic and pregnancy outcomes of IMSI and ICSI methods in patients with male factor infertility.
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General information
150
95
15095
150
80
15080
2018-09-22, 1397/06/31
2017-05-21, 1396/02/31
20182017-0905-2221 00:00:00
2016-04-20, 1395/02/01
2016-05-01, 1395/02/12
2016-0405-2001 00:00:00
2018-09-22, 1397/06/31
2017-08-01, 1396/05/10
20182017-0908-2201 00:00:00
2019-06-21, 1398/03/31
2018-05-01, 1397/02/11
20192018-0605-2101 00:00:00
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Record and update the latest changes applied in the study
Record and update the latest changes applied in the study
empty
ثبت و بروز رسانی آخرین تغییرات اعمال شده در مطالعه
ثبت و بروز رسانی آخرین تغییرات اعمال شده در مطالعه
Recruitment centers
#1
Name of recruitment center - English: Yazd Reproductive Sciences Institute
Name of recruitment center - Persian: پژوهشکده علوم تولید مثل یزد
Full name of responsible person - English: Abbas Aflatoonian
Full name of responsible person - Persian: عباس افلاطونیان
Street address - English: Bouali ave, safayieh
Street address - Persian: صفاییه، خیابان بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax: +98 35 3824 7087
Email: yazd-rsi@ssu.ac.ir
Web page address:
Name of recruitment center - English: Yazd Reproductive Sciences Institute
Name of recruitment center - Persian: پژوهشکده علوم تولید مثل یزد
Full name of responsible person - English: Abbas Aflatoonian
Full name of responsible person - Persian: عباس افلاطونیان
Street address - English: Bouali Ave, Safaeih
Street address - Persian: صفاییه، خیابان بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax: +98 35 3824 7087
Email: yazd-rsi@ssu.ac.ir
Web page address:
Name of recruitment center - English: Yazd Reproductive Sciences Institute Name of recruitment center - Persian: پژوهشکده علوم تولید مثل یزد Full name of responsible person - English: Abbas Aflatoonian Full name of responsible person - Persian: عباس افلاطونیان Street address - English: Bouali aveAve, safayiehSafaeih Street address - Persian: صفاییه، خیابان بوعلی City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Fax: +98 35 3824 7087 Email: yazd-rsi@ssu.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Robab Davar
Full name of responsible person - Persian: دکتررباب داور
Street address - English: Bu Ali Ave, timsar falahi Blvd, safaeieh, research and clinical center for infertility
Street address - Persian: پژوهشکده علوم تولیدمثل، صفائیه، خیابان تیمسارفلاحی، خیابان بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax:
Email: yazd-rsi@ssu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Robab Davar
Full name of responsible person - Persian: دکتر رباب داور
Street address - English: Buali Ave, Safaeih
Street address - Persian: صفائیه، خیابان بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8916877391
Phone: +98 35 3824 7085
Fax:
Email: yazd-rsi@ssu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Robab Davar Full name of responsible person - Persian: دکترربابدکتر رباب داور Street address - English: Bu AliBuali Ave, timsar falahi Blvd, safaeieh, research and clinical center for infertilitySafaeih Street address - Persian: پژوهشکده علوم تولیدمثل، صفائیه، خیابان تیمسارفلاحی، خیابان بوعلی City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8916877391 Phone: +98 35 3824 7085 Fax: Email: yazd-rsi@ssu.ac.ir Web page address:
Protocol summary
Study aim
Assessment and comparison of sperm apoptosis, embryo cytokinetic and pregnancy outcomes of IMSI and ICSI methods in patients with male factor infertility.
Design
Patients referred to the Yazd Infertility Center who had male infertility and entered the ART cycles. The cases who had oocytes retrieval on Saturday and Wednesday randomly divided into two groups of control and intervention by computer‐generated random numbers.
Settings and conduct
This study was conducted at the Yazd Infertility Center for improving the results of the treatment of male infertile patients who were treated several times and did not respond.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Male factor infertility
2) At least 3 years of primary infertility
3) The woman being 38 years or younger
4) An undetected female factor
Exclusion criteria:
Non-ejaculated spermatozoa (TESE,..)and ejaculates below 1million sperm/ml.
The cases that hadn’t good embryos for transfer.
Intervention groups
Control group: sperm selection was done at × 400 magnification and then injected into mature oocytes.
Intervention group: sperm selection was done at × 6000 magnification and then injected into mature oocytes.
Main outcome variables
Improved sperm and embryo selection methods and pregnancy outcomes in ART cycles
General information
Reason for update
Record and update the latest changes applied in the study
Acronym
IRCT registration information
IRCT registration number:IRCT20180130038561N1
Registration date:2020-07-04, 1399/04/14
Registration timing:retrospective
Last update:2021-07-25, 1400/05/03
Update count:1
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
Esmat Mangoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
es.mangoli@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-05-21, 1396/02/31
Actual recruitment start date
2016-05-01, 1395/02/12
Actual recruitment end date
2017-08-01, 1396/05/10
Trial completion date
2018-05-01, 1397/02/11
Scientific title
Assessment and comparison of sperm apoptosis, embryo cytokinetic and pregnancy outcomes of IMSI and ICSI methods in patients with male factor infertility.
Public title
Embryo cytokinetic and pregnancy outcome in ICSI and IMSI cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with male factor infertility
At least a history of 3 years primary infertility
Woman had less than 38 years old without any infertility problem
Exclusion criteria:
Azoospermic patients(testicular and epididymal samples)
The cases that hadn’t good embryos for transfer
Total freeze cycles
Age
To 38 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
95
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The mechanism of randomization was simple and individual randomization. No stratified randomization was used. Randomization was performed using a random number table. The random sequence was consecutive. No allocation concealment was applied.
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 medicine faculty Shahid Sadoughi University of Medical Science
Street address
BouAli Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2015-11-25, 1394/09/04
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.338
Health conditions studied
1
Description of health condition studied
Male infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Positive chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Beta HCG test
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Detection of one or more gestational sac with a fetal heartbeat after 6 weeks
Method of measurement
Ultrasound
Intervention groups
1
Description
Intervention group: sperm selection was done at x 6000 magnification and then injected into mature oocytes.
Category
Treatment - Devices
2
Description
Control group: sperm selection was done at x 400 magnification and then injected into mature oocytes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
yazd-rsi@ssu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Robab Davar
Street address
Buali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
yazd-rsi@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Esmat Mangoli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
es.mangoli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Esmat Mangoli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
es.mangoli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Esmat Mangoli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
es.mangoli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared after people have not been identified.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
The data are only available for people working in academic institutions.
Under which criteria data/document could be used
By requesting the Yazd Reproductive Sciences Research Institute, it is possible to teach the relevant technique in medical centers.
From where data/document is obtainable
Applicants for documents and data can receive information from Dr. Mangali through the e-mail address es.mangoli@gmail.com or by referring to the Research Institute of Reproductive Sciences of Yazd in the embryology department.
What processes are involved for a request to access data/document
Receipt of this data is done by mentioning the reason for using them and also agreeing to use the cooperation of a research institute professor in your study as a guide or clinical consultant.