The aim of our study is to select patients with repeated implantation failure (RIF) based on immunological disorders and their treatment with Lymphocyte. The study included 20 patients with repeated implantation failure at the age of 20 to 40 years. In this study, the informed consent will be obtained from the target population (people with RIF referred to Al-Zahra Hospital). Inclusion criterion includes the failure of IVF at least 3 times and exclusion criterion includes chromosomal disorders. To stimulate ovulation the GnRH antagonist is injected subcutaneously. Separation of PBMCs will be carried out by a ficole and then they will be cultured. Two days before embryo transfer(ET), PBMC will be injected into the uterine cavity by the catheter.
To obtain peripheral blood mononuclear cell (PBMC) from peripheral blood, a blood sample will be taken from patients with RIF on ovulation day and 14 days after the embryo transfer, a biochemical pregnancy is evaluated by measuring the serum βhCG protein by ELISA technique and the rate of fetal implantation based on the gestational sac and sonography at 6th or 7th week of gestation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081227520N8
Registration date:2017-09-15, 1396/06/24
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-09-15, 1396/06/24
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences, Tabriz, Iran
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intrauterine lymphocyte therapy on fertility in women with recurrent implantation failure (RIF): Clinical Trial
Public title
Lymphocyte therapy and treatment of recurrent implantation failure (RIF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having at least three implantation failures after IVF; Having primary infertility; The endometrial thickness less than 6 mm on ovulation induction day with HCG; Age under 40 years old; Having regular menstrual cycles; BMI under 30; no uterine pathology. Exclusion criteria: Having Polycystic ovarian syndrome ;The presence of uterine pathology; Poor ovarian reserve; Having chromosomal abnormalities ; presence of antiphospholipid antibody; presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S 7; patients who have HIV, HCV or HBV positive tests.
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Postal code
Approval date
2017-07-31, 1396/05/09
Ethics committee reference number
lR.TBZMED.REC.1396.36
Health conditions studied
1
Description of health condition studied
Recurrent implantation failure
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Embryo Implantation
Timepoint
2 months after intervention
Method of measurement
Laboratory tests and ultrasound
Secondary outcomes
1
Description
The frequency of Th1 cells
Timepoint
2 month after intervention
Method of measurement
Flow cytometry
2
Description
The frequency of Th2 cells
Timepoint
2 month after intervention
Method of measurement
Flow cytometry
3
Description
The expression level of cytokine by Th1 cells
Timepoint
2 months after intervention
Method of measurement
RT-PCR
4
Description
The expression level of cytokine by Th2 cells
Timepoint
2 months after intervention
Method of measurement
RT-PCR
5
Description
The amount of secreted cytokine by Th1 cells
Timepoint
2 months after intervention
Method of measurement
ELISA
6
Description
The amount of secreted cytokine by Th2 cells
Timepoint
2 months after intervention
Method of measurement
ELISA
Intervention groups
1
Description
To stimulate ovulation using antagonistic protocol, the GnRH antagonist is injected subcutaneously then intramuscular HCG will be injected. Ovulation will be performed 36 hours after HCG injection and after the oocyte preparation for fertilization, the ICSI method will be used. To obtain PBMC from peripheral blood, a blood sample will be taken from patients with RIF on ovulation day and will be stored in citrate tubes. Separation of PBMCs will be carried out by a ficole and then they will be cultured. Two days before embryo transfer(ET), PBMC will be injected into the uterine cavity by the catheter.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center at Alzahra Hospital
Full name of responsible person
Mehdi Yousefi
Street address
Infertility center at Alzahra Hospital, Bghshomal Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Nouri
Street address
Stem Cell And Regenerative Medicine Institute, Madani Hospital, Golbad Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Stem Cell And Regenerative Medicine Institute
Full name of responsible person
Mehdi Yousefi
Position
PhD in Medical Immunology
Other areas of specialty/work
Street address
Stem Cell And Regenerative Medicine Institute, Madani Hospital, Golbad Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 4665
Fax
Email
mehdi_yusefi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Stem Cell And Regenerative Medicine Institute
Full name of responsible person
Mehdi Yousefi
Position
PhD in Immunology
Other areas of specialty/work
Street address
Stem Cell And Regenerative Medicine Institute, Madani Hospital, Golbad Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 4665
Fax
Email
mehdi_yusefi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanam Dolati
Position
PhD in Immunology
Other areas of specialty/work
Street address
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)