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IRCT20180619040147N3 IRCT 2020-05-19 Iranian academic center for education culture and research Evaluation and comparison of the safety and effectiveness of Intra uterine injection of autologous menstrual blood-derived stem cells (MenSCs) and PRP in unfertilized women with thin unfunctional endometrium Evaluation and comparison of the safety and effectiveness of intra utrine injection of autologous menstrual blood-derived stem cells (MenSCs) and PRP in unfertilized women with thin unfunctional endometrium 2020-05-21 anticipated 36 Complete https://irct.ir/trial/47658 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization: In order to randomly assign 36 subjects in the treatment group or control group, 6 blocks including 6 subjects each will be defined using "https://app.studyrandomizer.com". Treatment group and control group will be identified by codes A and B, respectively. In each block, the number of treatment groups and control groups is equal and the situation of each block with other blocks is different. 1-2 thin endometrium. Intervention 1: Intervention group: includes 18 patients with thin endometrium that will be treated by once injection of autologous menstrual blood stem cells. After cells isolation, culture, and qualification in GMP grade- clean room of STERCO (Tehran, Iran), a suspension with a density of 10 million cells will be intravaginally injected by vaginal ultrasonography into the endometrium of patients after receiving general anesthesia. Intervention 2: Control group: includes 18 patients with thin endometrium that will not receive any stem cells and they will only receive PRP into the endometrium under general anesthesia and their biochemical parameters, sonographic and embryologic data will be compared with intervention group. 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 information.
public Somaieh Kazemnejad
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
tehran Iran (Islamic Republic of) 1936773493 +98 21 2243 2020 kazemnejad_s@yahoo.com Iranian academic center for education culture and research scientific Somaieh Kazemnejad
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1936773493 +98 21 2243 2020 kazemnejad_s@yahoo.com Iranian academic center for education culture and research Iran (Islamic Republic of) married women under 7 mm thickness of endometrium showing 3-4 Appelbaum classification of endometrium tissue pattern minimum or no blood supply of zone 3 of endometrium score 1-0 of arterial blood flow into endometrium intrauterine adhesions a history of no responding to routine treatment for this issue having at least 2 high quality embryos in freeze cycle ages between 25-40 25 years 40 years Female Thyroid disfunction Immune disorders history of cancer, chemotherapy and radiotherapy hepatitis B, C and HIV infections severe endometriosis diabetes Dysfunction of electrolyte or liver tests R93.4 Abnormal findings on diagnostic imaging of urinary organs Treatment - Other Treatment - Other Intervention group: includes 18 patients with thin endometrium that will be treated by once injection of autologous menstrual blood stem cells. After cells isolation, culture, and qualification in GMP grade- clean room of STERCO (Tehran, Iran), a suspension with a density of 10 million cells will be intravaginally injected by vaginal ultrasonography into the endometrium of patients after receiving general anesthesia Control group: includes 18 patients with thin endometrium that will not receive any stem cells and they will only receive PRP into the endometrium under general anesthesia and their biochemical parameters, sonographic and embryologic data will be compared with intervention group. Endometrium thickness. Timepoint: 1, 2 and 3rd month after injection. Method of measurement: Vaginal sonography. Uterine arterial blood flow. Timepoint: 1, 2 and 3rd month after injection. Method of measurement: Vaginal sonography. Blood flow precence into zone 3 of the endometrium. Timepoint: 1, 2 and 3rd month after injection. Method of measurement: vaginal sonography. Endomtrial tissue pattern. Timepoint: 1, 2 and 3rd month after injection. Method of measurement: vaginal sonography. Implantation rate. Timepoint: in new intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: vaginal sonography. Clinical pregnancy. Timepoint: 6-8 weeks after last menstrual period. Method of measurement: Vaginal sonography. Live birth. Timepoint: 9 months after pregnancy. Method of measurement: delivery report based on gynecologist comment. Iranian academic center for education culture and research Approved 2020-02-23 Academic Center for Education, Culture and Research (ACECR)- Biomedical Research Ethics Committee 1270, Secretariat of the Ethics Committee of ACECR,Deputy Director of Research and Technology, Headquarters of ACECR, Opposite the main door of Tehran University, Enghelab Street, Tehran tehran Tehran Iran (Islamic Republic of)