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IRCT20210513051280N2 IRCT 2021-05-31 Iranian academic center for education culture and research Evaluation of the effect of menstrual blood stem cells in recurrent pregnancy loss Assessment of safety and effectiveness of intrauterine infusion of allogeneic menstrual blood stem cells in women with unexplained recurrent pregnancy loss: A double-blind phase 1 and 2 clinical trial 2021-07-21 anticipated 40 Complete https://irct.ir/trial/56295 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization: In order to randomly assign 40 subjects in treatment group or control group, 10 blocks including 4 subjects each will be defined using "https://app.studyrandomizer.com". Blocks are small and balanced with predetermined group assignments, which keeps the numbers of subjects in each group similar at all times. Treatment group and control group will be identified by codes A and B, respectively. In each block, number of treatment group and control group is equal with assigning ratio of 1:1, Blinding description: Neither participants nor clinical care or analyzers are aware of the type of intervention. 1-2 Recurrent pregnancy loss. Intervention 1: Intervention group: A single dose of intrauterine infusion of allogeneic decidualized menstrual blood stem cells with final volume of 0.5 ml containing 1 million cells. Intervention 2: Control group: A single dose of intrauterine infusion of sterile phosphate buffer. Yes - There is a plan to make this available What will be shared: Protocol and the results of primary and secondary consequences When: After patent registry To whom: Investigators of universities and research institutes Conditions: Research use Where to obtain: Avicenna Research Institute, Amir-Hassan Zarnani How to obtain: Formal written request to Avicenna Research Institute Chancellor Comments:
public Amir-Hassan Zarnani
Avicenna Research Institute, Opposite to Faculty of Computer, Shahid Beheshti University, Evin, Chamran Highway, Tehran
Tehran Iran (Islamic Republic of) 2122432020 +98 21 2243 2020 zarnania@gmail.com Iranian academic center for education culture and research scientific Amirhossein Zarnani
Avicenna Research Institute, Opposite to Faculty of Computer, Shahid Beheshti University, Evin, Chamran Highway, Tehran
Tehran Iran (Islamic Republic of) 2122432020 +98 21 2243 2020 zarnania@gmail.com Iranian academic center for education culture and research Iran (Islamic Republic of) Women with primary recurrent pregnancy losses (at least two successive pregnancy losses excluding blighted ovum confirmed by sonography or pathology till 10th week of gestation Maximum patient age: 37 years, no history of previous live birth FSH level of less than 10 mIU/mL Negative test results for HIV, HBS Ag, HCV and VDRL 20 years 37 years Female Having previous history of successful pregnancy Chromosomal abnormalities in parents Uterine anatomic abnormalities Hormonal abnormalities PCO with metabolic syndrome Uncontrolled diabetes Stage 3 or 4 endometriosis Autoimmune diseases including rheumatoid arthritis, thyroid autoimmunity, lupus and anti-phospholipid antibodies History of cancer, chemotherapy and radiotherapy Spermogram abnormalities (DFI more than 30 and normal sperm morphology less than 2% History of immunosuppressive drugs intake including corticosteroids during the past three months XV Pregnancy, childbirth and the puerperium Treatment - Other Other Intervention group: A single dose of intrauterine infusion of allogeneic decidualized menstrual blood stem cells with final volume of 0.5 ml containing 1 million cells. Control group: A single dose of intrauterine infusion of sterile phosphate buffer Pregnancy loss. Timepoint: Before 20th week of gestation. Method of measurement: Sonography. Clinical pregnancy rate. Timepoint: 6th week of pregnancy. Method of measurement: Sonography. Live birth rate. Timepoint: At the end of pregnancy period. Method of measurement: Delivery. Twin pregnancy. Timepoint: 6th week of gestation. Method of measurement: Sonography. Newborn weight. Timepoint: After delivery. Method of measurement: Weighting. Iranian academic center for education culture and research Approved 2021-03-15 Academic Center for Education, Culture and Research (ACECR)- biomedical research ethics committee No.1270, Secretariat of the Ethics Committee of ACECR, Deputy of Research and Technology, Headquarter of ACECR, Opposite the main door of Tehran University, Enghelab street, Tehran Tehran Tehran Iran (Islamic Republic of)