Comparison of the effect of using or not using of artificial oocyte activation on intra-Cytoplasmic sperm injection outcomes in infertile patients with phospholipase C ζ deficiency
Comparison of the effect of using or not using of artificial oocyte activation on intra-Cytoplasmic sperm injection outcomes in infertile patients with phospholipase C ζ deficiency
Design
In this study, PLCζ will be used as a diagnostic biomarker in couples subjected to intra-cytoplasmic sperm injection (ICSI). The oocytes obtained from patients who are deficient in this protein, will be randomly divided into two parts following the ICSI method. Assisted oocyte activation (AOA) will be used for one part of oocytes (group treatment, n=110), while the other part will not be received AOA (control group, n=110). Finally, the effect of AOA on fertilization rate, embryo cleavage, and embryo quality will be evaluated in preimplantation embryos microscopically and will be compared between groups.
Settings and conduct
Semen samples from infertile men referred to infertility clinic of Taleghani hospital will be assessed by PLCζ immunofluorescence staining.
Participants/Inclusion and exclusion criteria
By evaluating PLCζ, measured by immunofluorescence staining, semen samples with PLCζ deficiency will be determined and entered to the study.
Intervention groups
1- Group treatment: one part of oocytes that will recieve assisted oocyte activation (AOA).
1- Group control: other part of oocytes that will not recieve AOA.
Main outcome variables
The comparison of fertilization rate, embryo cleavage, and embryo quality in preimplantation stage in infertile patients with PLCζ deficiency in studied groups
General information
Reason for update
Acronym
AOA
IRCT registration information
IRCT registration number:IRCT20160722029027N4
Registration date:2018-01-21, 1396/11/01
Registration timing:retrospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of using or not using of artificial oocyte activation on intra-Cytoplasmic sperm injection outcomes in infertile patients with phospholipase C ζ deficiency
Public title
Effect of artificial oocyte activation on intra-Cytoplasmic sperm injection outcomes in specific infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
couples subjected to ICSI cycles
male factor infertility
Exclusion criteria:
any history of trauma and surgery in the testis
age >40 years in men
any female factor infertility such as endometriosis and poly cystic ovarian syndrome (PCOs)
age >35 years in women
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In the study, the oocytes derived from each couple in the ICSI cycle are randomly divided into two groups of control and treatment.
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 commitee of Shahid Beheshti University
Street address
Shahid chamran highway, Evin, next to Taleghani hospital
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.SBMU.MSP.REC.1395.93.
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
Fertilization rate
Timepoint
3 days
Method of measurement
obsrevation with loop microscope
2
Description
embryo cleavage
Timepoint
3 days
Method of measurement
obsrevation with loop microscope
3
Description
embryo quality
Timepoint
3 days
Method of measurement
obsrevation with loop microscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention= exposing oocytes in calcium ionophore A23187 following ICSI for 10 min and 10mM (sigma-aldrich). A23187 facilitate passing Ca iones from oocyte' s membrane.
Category
N/A
2
Description
Control= putting oocytes in culture medium following ICSI without calcium ionophore. The procedure is similar to conventional ICSI cycles.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and IVF ward of Talghani hospital
Full name of responsible person
Dr. Leila Nazari
Street address
Yaman St, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
nazari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Azad
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
193954719
Phone
+98 21 2387 2555
Fax
Email
nazad1390@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Fellowship of Infertility
Latest degree
Specialist
Other areas of specialty/work
infertility
Street address
Yaman St, Velenjak, Chamran highway, Infertility and IVF ward of Talghani hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
Email
nazari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Azad
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1655133931
Phone
+98 21 2387 2555
Fax
Email
nazad1390@gmail.com
Web page address
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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
IPD collected for the primary outcome measure will be shared.
When the data will become available and for how long
6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
increasing the clinical information and for review articles
From where data/document is obtainable
via email address: nazad1390@gmail.com
What processes are involved for a request to access data/document
Access will be done with the opinion of the professors involved in the work