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IRCT2017081227520N8 IRCT 2017-09-15 Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences PBMC-therapy and treatment of recurrent implantation failure (RIF) The effect of peripheral blood mononuclear cells (PBMC) on pregnancy outcomes in patients with recurrent implantation failure (RIF): randomized control trial study 2017-09-23 anticipated 100 Complete https://irct.ir/trial/22525 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: From 248 volunteer patients, after immunologic consultation and flow cytometry analysis,100 women were finally selected. these 100 patients were randomly divided into two groups: 50 patients for intrauterine injection of PBMC activated by hCG before embryo transfer (ET) and 50 patients as control group undergoing intrauterine insemination of phosphate buffer saline (PBS) as a placebo before ET. One hundred healthy women were selected as the healthy control group for the selection of enrolled women, Randomization description: At first, the sample size of 100 patients with RIF that met our inclusion criteria was considered as the total sample size. 'Random allocation rule' method was used for randomization, where numbers were randomly assigned to cards on a random order of one to 100. Even numbers were assigned to the treatment group and odd numbers to the placebo group. In this method, the balance will be reached at the end of the study in the number of people assigned to each group. Each card was placed in sealed and opaqued envelopes to hide the random assignment, Blinding description: The participants and the person who analyzed the results were blinded in this study. Participants were aware of the study before being randomized and informed consent was obtained from them. It should be noted that the person analyzing the results had no other role in this study. 1-2 Recurrent implantation failure. Intervention 1: Intervention group: blood sampling was done (20ml) five days before embryo transfer. Then PBMCs were isolated by Ficol and 20-30 million cells were cultured 48 hours in the presence of hCG. After 48 hours, 15-20 million PBMCs in 500 microliters PBS was administered into the uterine cavity two days before embryo transfer using embryo transfer catheter. Intervention 2: Control group: Similar to study group, blood sampling was done in this group but only 500 microliters PBS two days before embryo transfer was injected into uterine cavity. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more data
public Mehdi Yousefi
Stem Cell And Regenerative Medicine Institute, Madani Hospital, Golbad Ave, Tabriz
Tabriz Iran (Islamic Republic of) 6446-14155 +98 41 3336 4665 mehdi_yusefi@yahoo.com Stem Cell And Regenerative Medicine Institute scientific Mehdi Yousefi
Stem Cell And Regenerative Medicine Institute, Madani Hospital, Golbad Ave, Tabriz
Tabriz Iran (Islamic Republic of) 6446-14155 +98 41 3336 4665 mehdi_yusefi@yahoo.com Stem Cell And Regenerative Medicine Institute Iran (Islamic Republic of) Having at least three implantation failures after IVF Having primary infertility Age under 45 years old Having regular menstrual cycles BMI under 30 20 years 45 years Female Having polycystic ovarian syndrome The presence of uterine pathology; Poor ovarian reserve Having chromosomal abnormalities Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, and anti-dsDNA Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S Positive HIV, HCV or HBV tests N98.9 Complication associated with artificial fertilization, unspecified Treatment - Other Placebo Intervention group: blood sampling was done (20ml) five days before embryo transfer. Then PBMCs were isolated by Ficol and 20-30 million cells were cultured 48 hours in the presence of hCG. After 48 hours, 15-20 million PBMCs in 500 microliters PBS was administered into the uterine cavity two days before embryo transfer using embryo transfer catheter. Control group: Similar to study group, blood sampling was done in this group but only 500 microliters PBS two days before embryo transfer was injected into uterine cavity. Pregnancy rate. Timepoint: After positive beta-hCG test, clinical pregnancy was evaluated at 5-6 week. Method of measurement: Laboratory tests and ultrasound. -NCT03267797 -WWW.clinicaltrial.gov Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences Approved 2018-01-01 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences , Daneshghah st, Tabriz, Tabriz East Azarbaijan Iran (Islamic Republic of)