Protocol summary
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Study aim
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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
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Design
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In this clinical trial study all women who have entered in the study were divided in two groups: lymphocyte therapy and control group.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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This clinical trial is conducted on infertile women who have a history of RIF.
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Intervention groups
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A group of patients is in the lymphocyte therapy cycle.
The control group
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Main outcome variables
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The mRNA and protein expression of the estrogen receptor and progesterone in uterus endometrium
General information
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Reason for update
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sample size revision
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140707018381N3
Registration date:
2018-07-30, 1397/05/08
Registration timing:
registered_while_recruiting
Last update:
2023-03-19, 1401/12/28
Update count:
4
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Registration date
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2018-07-30, 1397/05/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-01-06, 1396/10/16
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Expected recruitment end date
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2019-08-05, 1398/05/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Evaluation effect intrauterine administration of peripheral blood lymphocyte cells on expression of endometrial estrogen and progesterone receptor
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
22
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed using computer-generated tables.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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All qualitative and quantitative assessment of samples was done by a single, blinded investigator.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-17, 1395/04/27
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1395.402
Health conditions studied
1
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Description of health condition studied
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Infertility
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ICD-10 code
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N97.9
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ICD-10 code description
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Female infertility, unspecified
Primary outcomes
1
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Description
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The mRNA levels of both estrogen receptors and progesterone receptors in endometrial tissues
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Timepoint
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at the implantation window time, during the mid-secretory phase (LH+7 days) of each menstrual cycle
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Method of measurement
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The sample of tissue is analyzed using the quantitative real-time polymerase chain reaction (qRT-PCR) technique
Secondary outcomes
1
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Description
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The protein expression estrogen receptors and progesterone receptors in endometrial tissues
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Timepoint
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at the implantation window time, during the mid-secretory phase (LH+7 days) of each menstrual cycle
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Method of measurement
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immunohistochemical staining
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Get started 6 months after publishing study results
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To whom data/document is available
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The findings of this study will be accessible to all individuals.
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Under which criteria data/document could be used
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To improve pregnancy outcomes in infertility clinics
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From where data/document is obtainable
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Dr Fattaneh Farifteh
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What processes are involved for a request to access data/document
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Receiving the author's confirmation and obtaining approval from the director of the Infertility Clinic of the Erfan Hospital
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Comments
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