Evaluation effect intrauterine administration of peripheral blood lymphocyte cells on expression of endometrial estrogen and progesterone receptor on implantation window in women with repeated implantation failure
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General information
Not blinded
Single blinded
notblsingl
1
1
1
1
All qualitative and quantitative assessment of samples was done by a single, blinded investigator.
All qualitative and quantitative assessment of samples was done by a single, blinded investigator.
کلیه ارزیابی های کیفی و کمی نمونه های مورد بررسی توسط یک محقق به صورت کور انجام شد.
کلیه ارزیابی های کیفی و کمی نمونه های مورد بررسی توسط یک محقق به صورت کور انجام شد.
Protocol summary
Study aim
Determination the effect of intrauterine administration of peripheral blood lymphocyte cells on expression of endometrial estrogen and progesterone receptor on implantation window in women with repeated implantation failure
Design
In this clinical trial study all women who have entered in the study were divided in two groups: lymphocyte therapy and control group.
Settings and conduct
A group of patients is in the lymphocyte therapy cycle. Five days before endometrial biopsy, 5 cc blood samples were taken and their peripheral blood lymphocytes were immediately isolated on the same day, and 48-72 hours were placed in the medium. Then, 2 days before endometrial biopsy, a single dose of 0.4 CC lymphocytes is injected into the uterus with an IUI catheter. The biopsy samples will be prepared for qPCR and immunohistochemical staining.
The control group haven’t any blood samplings and lymphocyte injections into the uterus. The endometrial biopsy will be performed, at the implantation window time of each menstrual cycle. The biopsy samples will be prepared for qPCR and immunohistochemical staining. The estrogen and progesterone receptor expression in uterus endometrium is measured by qPCR and immunohistochemical staining technique.
Participants/Inclusion and exclusion criteria
This clinical trial is conducted on infertile women who have a history of RIF.
Intervention groups
A group of patients is in the lymphocyte therapy cycle.
The control group
Main outcome variables
The mRNA and protein expression of the estrogen receptor and progesterone in uterus endometrium
General information
Reason for update
article revision
Acronym
IRCT registration information
IRCT registration number:IRCT20140707018381N3
Registration date:2018-07-30, 1397/05/08
Registration timing:registered_while_recruiting
Last update:2022-08-06, 1401/05/15
Update count:4
Registration date
2018-07-30, 1397/05/08
Registrant information
Name
Ahmad Hosseini
Name of organization / entity
Shahid Beheshty University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 9153
Email address
ahmad-hosseini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-06, 1396/10/16
Expected recruitment end date
2019-08-05, 1398/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect intrauterine administration of peripheral blood lymphocyte cells on expression of endometrial estrogen and progesterone receptor on implantation window in women with repeated implantation failure
Public title
Evaluation effect intrauterine administration of peripheral blood lymphocyte cells on expression of endometrial estrogen and progesterone receptor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least ≥3 previous implantation failure in IVF or ICSI cycles
No history of clinical pregnancy (primary infertility)
not receiving any steroidal hormone ≥ 2 months were entered in this study
Exclusion criteria:
genetic disorders
history of repeated infectious diseases
Endometriosis
uterine anatomic abnormalities
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using computer-generated tables.
Blinding (investigator's opinion)
Single blinded
Blinding description
All qualitative and quantitative assessment of samples was done by a single, blinded investigator.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Faculty of Medicine, Arabi Ave., Daneshjo street, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.402
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
The mRNA levels of both estrogen receptors and progesterone receptors in endometrial tissues
Timepoint
at the implantation window time, during the mid-secretory phase (LH+7 days) of each menstrual cycle
Method of measurement
The sample of tissue is analyzed using the quantitative real-time polymerase chain reaction (qRT-PCR) technique
Secondary outcomes
1
Description
The protein expression estrogen receptors and progesterone receptors in endometrial tissues
Timepoint
at the implantation window time, during the mid-secretory phase (LH+7 days) of each menstrual cycle
Method of measurement
immunohistochemical staining
Intervention groups
1
Description
Intervention group: A group of patients are in lymphocyte therapy group. Five days before endometrial biopsy, 5 cc blood samples were taken and their peripheral blood lymphocytes were immediately isolated on the same day, and 48-72 hours were placed in the medium. Then, 2 days before endometrial biopsy, a single dose of 0.4 CC lymphocytes are injected into the uterus with an IUI catheter. Endometrial biopsy will be performed, at the implantation window time, during the mid-secretory phase (LH+7 days) of each menstrual cycle. The biopsy samples will be prepared for qPCR and immunohistochemical staining.
Category
Treatment - Drugs
2
Description
Control group: The control group haven’t any blood samplings and lymphocyte injections into the uterus. The endometrial biopsy will be performed, at the implantation window time, during the mid-secretory phase (LH+7 days) of each menstrual cycle. The biopsy samples will be prepared for qPCR and immunohistochemical staining.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Genetics & In Vitro Assisted Reproductive (GIVAR) center, Erfan hospital
Full name of responsible person
Dr. Fattaneh Farifteh
Street address
Erfan hospital, Bakhshayesh St, Sarv st., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2235 8435
Fax
+98 21 8867 8159
Email
f.farifteh@gmail.com
Web page address
http://phasco.com/LabDirectory.aspx?lid=853
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ahmad Hosseini
Street address
Shahid Beheshti University of medical science, Arabi Ave, daneshjo st, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9956
Email
profhosseini@yahoo.com
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
Dr Fattaneh Farifteh
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Shahid Beheshti University of medical science, Arabi Ave, daneshjo st, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9956
Email
f.farifteh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Fattaneh Farifteh
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Shahid Beheshti University of medical science, Arabi Ave, daneshjo st, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2235 9153
Email
f.farifteh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Fattaneh Farifteh
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Shahid Beheshti University of medical science, Arabi Ave, daneshjo st, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2235 9153
Email
f.farifteh@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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All interventions in the patient's file will be recorded and archived in the Erfan hospital. All data obtained from this study will be released after being unidentified studies participants.
When the data will become available and for how long
Get started 6 months after publishing study results
To whom data/document is available
The findings of this study will be accessible to all individuals.
Under which criteria data/document could be used
To improve pregnancy outcomes in infertility clinics
From where data/document is obtainable
Dr Fattaneh Farifteh
What processes are involved for a request to access data/document
Receiving the author's confirmation and obtaining approval from the director of the Infertility Clinic of the Erfan Hospital