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
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 are in the frozen/thawed embryo transfer lymphocyte therapy cycle. Five days before embryo transfer, 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, a single dose of 0.4 CC lymphocytes are injected into the uterus with an IUI catheter. Embryos are not transfer to the uterus and freeze. On the third day, after the injection of lymphocytes, the endometrial biopsy was done and stored in a RNA Later solution. The control group haven’t any blood samplings and lymphocyte injection into the uterus.On the third day, after the oocytes pick up, an endometrial biopsy is performed on the control group and stored in a RNA Later solution. The expression of the estrogen receptor and progesterone genes in uterus endometrium is measured by Real-Time qRT-PCR technique.
Participants/Inclusion and exclusion criteria
This clinical trial is conducted on women who have been treated in frozen/thawed infertility treatment cycles and have a history of RIF.
Intervention groups
A group of patients are in the frozen/thawed embryo transfer lymphocyte therapy cycle.
The control group
Main outcome variables
The expression of the estrogen receptor and progesterone genes in uterus endometrium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140707018381N3
Registration date:2018-07-30, 1397/05/08
Registration timing:registered_while_recruiting
Last update:2018-07-30, 1397/05/08
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
2017-03-19, 1395/12/29
Expected recruitment end date
2018-11-01, 1397/08/10
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)
No poor ovarian reserve (FSH <15 mIU/ml)
Endometrial thickness 7< in ovulation induction time
BMI < 30
Exclusion criteria:
Women with history of repeated infectious diseases in the past
Endometriosis
Uterine pathology such as uterine lymphomas
The known etiology of recurrent implantation failure as chromosomal disorders were excluded from the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
By random number table couples that participated in the study divided into experiments and control groups.
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 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
Uterus endometrial biopsy
Timepoint
On the third day after oocyte pick up.
Method of measurement
The sample of tissue is analyzed under a microscope in the laboratory
Secondary outcomes
1
Description
Estrogen receptor alpha
Timepoint
On the third day after oocyte pick up
Method of measurement
Real-Time PCR
2
Description
Estrogen receptor beta
Timepoint
On the third day after oocyte pick up
Method of measurement
Real-Time PCR
3
Description
Progesterone receptor alpha
Timepoint
On the third day after oocyte pick up
Method of measurement
Real-Time PCR
4
Description
Progesterone receptor beta
Timepoint
On the third day after oocyte pick up
Method of measurement
Real-Time PCR
Intervention groups
1
Description
Intervention group: A group of patients are in the frozen/thawed embryo transfer lymphocyte therapy cycle. Five days before embryo transfer, 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, a single dose of 0.4 CC lymphocytes are injected into the uterus with an IUI catheter. Embryos are not transfer to the uterus and freeze. On the third day, after the injection of lymphocytes, the endometrial biopsy was done and stored in a RNA Later solution.
Category
Treatment - Drugs
2
Description
Control group: The control group haven’t any blood samplings and lymphocyte injection into the uterus.On the third day, after the oocytes pick up, an endometrial biopsy is performed on the control group and stored in a RNA Later solution.
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