Comparison effect intrauterine administration of peripheral blood lymphocyte cells on pregnancy outcome on patients with repeated implantation failure on fresh embryo transfer cycles and frozen/thawed embryo transfer cycles
The aim of this study was to determine effect of intrauterine administration of peripheral blood lymphocyte cells on pregnancy outcome on RIF’s patients.
Design
In this clinical trial study all women who have entered in the study were divided in three groups: fresh embryo transfer, frozen/thawed embryo transfer and control group.
Settings and conduct
In all three groups ovulation induction was done. After oocyte retrieval, cumulus cells were removed from oocytes then sperm was injected into denuded oocytes.
Participants/Inclusion and exclusion criteria
This clinical trial is conducted on women who have been treated in fresh and frozen/thawed infertility treatment cycles and have a history of RIF.
The criteria for entering the study include:
1. Having 3≤ failure in IVF or ICSI cycle
2. No poor ovarian reserve (FSH <15 mIU / ml)
3. No history of clinical pregnancy (primary infertility).
4. Endometrial thickness 7 < mm after ovulation induction
5. BMI <30
Exclusion criteria included:
1. History of repeated infectious diseases in the past
2. Endometriosis
3. Uterine pathologies including uterine myoma
4. Etiologies known as repeated implantation failure including chromosomal abnormalities
Intervention groups
1. A group of patients undergoing lymphocyte therapy in the fresh embryo transfer cycle. in these patients, 5 cc blood samples were taken in one day before day of HCG injection, and then their peripheral blood lymphocytes were isolated on the same day and 48-72hours were placed in the culture medium. On ovulation day, A single dose of 0.4 CC lymphocytes are injected into the uterus with an IUI catheter. The embryos transferred to the uterus on the second to third day with the embryo transfer catheter.
2-Another group of patients are in the freeze 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. 2-3 days after the injection of the lymphocytes, the frozen embryos are thawed and transferred to the uterus with the embryo transfer catheter.
3- control group haven't any blood sampling and lymphocyte injection into the uterus.
In all three groups, support for the luteal phase is performed by administering two cyclogest vaginal suppositories for up to two weeks. The blood BHCG is measured 14 days later.
Main outcome variables
Finally, the outcome of pregnancy is recorded in three groups and the pregnancy rate will be compared in three groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140707018381N2
Registration date:2017-12-03, 1396/09/12
Registration timing:retrospective
Last update:2017-12-03, 1396/09/12
Update count:0
Registration date
2017-12-03, 1396/09/12
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
Shahid Behashti University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect intrauterine administration of peripheral blood lymphocyte cells on pregnancy outcome on patients with repeated implantation failure on fresh embryo transfer cycles and frozen/thawed embryo transfer cycles
Public title
Comparison effect intrauterine administration of peripheral blood lymphocyte cells on pregnancy outcome on patients with repeated implantation failur
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion 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:
160
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.REC.1395.38
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
multiple pregnancy rate
Timepoint
14 weeks of pregnancy
Method of measurement
sonography
2
Description
abortion rate
Timepoint
20 weeks after pregnancy
Method of measurement
sonography
Secondary outcomes
1
Description
clinical pregnancy rate
Timepoint
after intervention
Method of measurement
sonography
Intervention groups
1
Description
1. A group of patients undergoing lymphocyte therapy in the fresh embryo transfer cycle. in these patients, 5 cc blood samples were taken in one day before day of HCG injection, and then their peripheral blood lymphocytes were isolated on the same day and 48-72 hours were placed in the culture medium. On ovulation day, A single dose of 0.4 CC lymphocytes are injected into the uterus with an IUI catheter. The embryos transferred to the uterus on the second to third day with the embryo transfer catheter.
Category
Treatment - Drugs
2
Description
2-Another 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. 2-3 days after the injection of the lymphocytes, the frozen embryos are thawed and transferred to the uterus with the embryo transfer catheter.
Category
Treatment - Drugs
3
Description
3. The control group haven’t any blood samplings and lymphocyte injection into the uterus
Category
N/A
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
Ahmad Hosseini
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
profhosseini@yahoo.com
Web page address
http://phasco.com/LabDirectory.aspx?lid=853
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
Private
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
Fattaneh Farifteh
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Shahid Beheshti University of medical science, Arabi Ave, daneshjo st, Velenjak, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 9956
Fax
+98 21 8867 8159
Email
f.farifteh@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
FattanehF Farifteh
Position
Assistant Professor
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
Fax
+98 21 8867 8159
Email
f.farifteh@gmail.com
Web page address
http://phasco.com/LabDirectory.aspx?lid=853
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fattaneh Farifteh
Position
Phd, Assistant Professor
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
Fax
+98 21 8867 8159
Email
f.farifteh@gmail.com
Web page address
http://phasco.com/LabDirectory.aspx?lid=853
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
Yes - There is a plan to make this available
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
he 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