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IRCT20140707018381N2 IRCT 2017-12-03 Shahid Beheshti University of Medical Sciences Comparison effect intrauterine administration of peripheral blood lymphocyte cells on pregnancy outcome on patients with repeated implantation failur 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 2016-03-19 anticipated 160 Complete https://irct.ir/trial/16689 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By random number table couples that participated in the study divided into experiments and control groups. 3 Infertility. Intervention 1: 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. Intervention 2: 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. Intervention 3: 3. The control group haven’t any blood samplings and lymphocyte injection into the uterus. Yes - There is a plan to make this available What will be shared: 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: Get started 6 months after publishing study results To whom: he findings of this study will be accessible to all individuals. Conditions: To improve pregnancy outcomes in infertility clinics Where to obtain: Dr Fattaneh Farifteh How to obtain: Receiving the author's confirmation and obtaining approval from the director of the Infertility Clinic of the Erfan Hospital Comments:
public Fattaneh Farifteh
Shahid Beheshti University of medical science, Arabi Ave, daneshjo st, Velenjak, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9956 f.farifteh@gmail.com Shahid Beheshti University of Medical Sciences scientific FattanehF Farifteh
Shahid Beheshti University of medical science, Arabi Ave, daneshjo st, Velenjak, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2235 9153 f.farifteh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 50 years Both 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 N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs N/A 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. 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. 3. The control group haven’t any blood samplings and lymphocyte injection into the uterus Multiple pregnancy rate. Timepoint: 14 weeks of pregnancy. Method of measurement: sonography. Abortion rate. Timepoint: 20 weeks after pregnancy. Method of measurement: sonography. Clinical pregnancy rate. Timepoint: after intervention. Method of measurement: sonography. Shahid Beheshti University of Medical Sciences Approved 2016-07-17 Ethics Committee of Shahid Beheshti University of Medical Sciences Faculty of medicine, Arabi Ave, Daneshjo street, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)