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IRCT20180619040147N4 IRCT 2020-08-01 Iranian academic center for education culture and research Effectiveness evaluation of intra-ovarian injection of autologous menstrual blood stem cells in fertility potential of patients with poor ovarian response: a controlled clinical trial study Effectiveness evaluation of intra-ovarian injection of autologous menstrual blood stem cells in fertility potential of patients with poor ovarian response: a controlled clinical trial study 2020-06-21 anticipated 180 Complete https://irct.ir/trial/49567 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization: For this study, a specific population of unfertilized diminished ovarian reserve patients was chosen, admission and exclusion criteria from the study were chosen very detailed and accurate. all the population was all the same in the range of age and weight, non-fertility period, normal sperm analysis of their spouses, therefore block randomized of 180 patients were divided into main group (A), control group (B). hence 18 blocks of 10 were created using Computer logarithm from the study randomized app (https://app.studyrandomizer.com). All the blocks were the same and both groups contained the same amount of samples (1:1), the state of each block was different from the next block. randomizing the samples was conducted as follows: First, based on a computer logarithm 180 sample (patient) was randomized. and for each sample, block identifier, block size, sequence within the block was designed. For example, the code 2,6,1 shows that the second patient in block no. 1 of 10 is located in the second seat. for each patient, a specific code (study ID) was defined based on standard coding, and therefore the master randomized list was created for the patients. 3 Poor ovarian response. Intervention 1: Intervention group: includes 90 patients with poor ovarian response 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), they will be intravaginally injected by vaginal ultrasonography into both ovaries of patients after receiving general anesthesia. Intervention 2: Control group: Iincludes 90 patients with poor ovarian response, being treated with IVF treatment cycles. 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 ages between 25-45 years old Picked up equal or less than 3 oocytes in last ovarian stimulation Anti mullerian hormone; less than 1.1 nanogram per milliliter Anteral follicles: less than 5-7 Spermogram: more than 5 million per millilieter normal morphology more than 1% 25 years 45 years Female un treated Thyroid dysfunction Immune disorders History of cancer, chemotherapy and radiotherapy Infected by hepatitis B,C or HIV Severe endometriosis History of ovarian surgery Diabetes Dysfunction of electrolyte or liver tests Psychological problem like depression, high stress an anxiety renal failure disease history of blood trasfusion, anemia or sickle cell anemia E89.40 Asymptomatic postprocedural ovarian failure Treatment - Other Treatment - Other Intervention group: includes 90 patients with poor ovarian response 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), they will be intravaginally injected by vaginal ultrasonography into both ovaries of patients after receiving general anesthesia. Control group: Iincludes 90 patients with poor ovarian response, being treated with IVF treatment cycles. Number of antral follicles in ovary. Timepoint: Before intervention, 3 months and 6 months after cell administration. Method of measurement: Vaginal sonography. Anti Mullerian hormone level in blood serum. Timepoint: Before intervention, 3 months, 6 months and one year after cell administration. Method of measurement: biochemical assay. Number and quality of oocytes in intra-cytoplasmic sperm injection cycle. Timepoint: first intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: embryologic evaluation. Spontaneous pregnancy. Timepoint: up to 3 months after intervention. Method of measurement: beta-HCG assay. 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. Embryo quality and number. Timepoint: in new intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: embryology report. Iranian academic center for education culture and research Approved 2020-05-31 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)