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IRCT20231230060569N1 IRCT 2024-04-01 Mazandaran University of Medical Sciences Stem cell therapy for infertile women with diminished ovarian reserve (DOR) Set up of new stem cell therapy method for infertile women with diminished ovarian reserve (DOR) by using autologous menstrual blood-derived stem cells and plasma rich platelet (PRP) 2024-01-21 anticipated 40 Complete https://irct.ir/trial/74695 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The output of this project is the acquisition of technical knowledge to create a new cell therapy protocol for DOR patients, and finally, after the evaluation of clinical trials, it can enter the health market as a knowledge-based and technological product or service, Randomization description: To allocate the samples to each group, the random block method will be used. For this purpose, patients will receive number 1 to 40 according to their arrival. The randomization unit will be individually and by number with blocks of 4 people. The selection of the group type for each person will be done through random allocation 2 statistical software. In order to make a random sequence, A, B, C, D codes will be generated from the software, and each code will be considered for one group. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment. 1-2 Diminished Ovarian Reserve(DOR). Intervention 1: Intervention group: Injection of 1 ml of autologous PRP in 1 step into the ovaries of DOR patients under mild anesthesia with ultrasound guidance. Intervention 2: Intervention group: Injection of 1 ml of stem cells derived from autologous menstrual blood in 1 step into the ovaries of DOR patients under mild anesthesia with ultrasound guidance. Intervention 3: Intervention group: Simultaneous injection of 1 ml of autologous PRP and stem cells derived from autologous menstrual blood in 1 step into the ovaries of DOR patients under mild anesthesia with ultrasound guidance. Intervention 4: Control group: No injection. 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 Ethical considerations
public Manizheh Habibpour
N0.94, Dolat Ave., Pasdaran Blvd., Sari Town
Sari Iran (Islamic Republic of) 4814979583 +98 11 3334 2905 manizheh.habibpour@yahoo.com Mazandaran University of Medical Sciences scientific Seyed Ehsan Enderami
Faculty of Modern Medical Technologies University, Complex of the Prophet (PBUH), Km 18 Khazarabad Road,Sari Town
Sari Iran (Islamic Republic of) 4847193711 +98 11 3354 3356 e.enderami@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Female 20 to 45 years old with DOR having a history of infertility for more than a year Rejecting IVF at least once The total number of antral follicles is less than 7 in two ovaries or the serum level of Anti Müllerin hormone is less than 1.1 ng/ml. Having a low egg count or low-quality embryos in an IVF cycle Absence of ovulation or amenorrhea that did not occur for at least three months before entering the study. 20 years 45 years Female Pregnant people IgA deficiency (before or now) Secondary ovarian failure caused by sex chromosomes. Taking anticoagulants History of mental illnesses with drug addiction Surgery leading to pelvic adhesions. Malignancy or chronic pelvic pain Infertility caused by strong male factor. Dissatisfaction with the intervention Abnormal uterine shape and endometrium caused by abscess. E28.9 Ovarian dysfunction, unspecified Treatment - Other Treatment - Other Treatment - Other Other Intervention group: Injection of 1 ml of autologous PRP in 1 step into the ovaries of DOR patients under mild anesthesia with ultrasound guidance Intervention group: Injection of 1 ml of stem cells derived from autologous menstrual blood in 1 step into the ovaries of DOR patients under mild anesthesia with ultrasound guidance Intervention group: Simultaneous injection of 1 ml of autologous PRP and stem cells derived from autologous menstrual blood in 1 step into the ovaries of DOR patients under mild anesthesia with ultrasound guidance Control group: No injection Anti Mullerian hormone. Timepoint: 2 weeks before and after injection. Method of measurement: ELISA KIT. Antral Follicle Count(AFC). Timepoint: 2 weeks before and after injection. Method of measurement: ELISA KIT. Estradiol. Timepoint: 2 weeks before and after injection. Method of measurement: ELISA KIT. FSH. Timepoint: 2 weeks before and after injection. Method of measurement: ELISA KIT. Pregnancy success rate. Timepoint: after delivery. Method of measurement: Observation. Embryo quality. Timepoint: 3 days after conception. Method of measurement: Microscope. Mazandaran University of Medical Sciences Approved 2023-01-04 Ethics committee of Mazandaran University of Medical Sciences No. 94, Dolat Ave., Pasdaran Blvd., Sari Town Sari Mazandaran Iran (Islamic Republic of)