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IRCT20231230060569N2 IRCT 2024-12-30 Kerman University of Medical Sciences Cell therapy in infertile women with Diminished Ovarian Reserve Investigating the effectiveness of autologous Platelet-Rich Plasma and Condition Medium of mesenchymal stem cells derived from the umbilical cord on the serum level of Anti Mullerian Hormone in infertile women with Diminished Ovarian Reserve 2025-01-20 anticipated 44 Complete https://irct.ir/trial/80860 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 samples to each group, the random block method will be used. For this purpose, patients will receive numbers 1 to 44 according to their arrival. The randomization unit will be individual and by number with blocks of 4 people. The selection of the type of group for each individual will be done through the statistical software 2 allocation random. To create a random sequence, the software will generate codes A, B, C, D, and each code will be considered for one group. Finally, the codes will be placed in a sealed envelope and the number of each patient will be written on the envelope. In the order of each patient's arrival, 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 Condition Medium of mesenchymal stem cells derived from umbilical cord 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 Condition Medium of mesenchymal stem cells derived from umbilical cord in 1 stage 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 Alireza Farsinejad
Beginning of Haft Bagh Alavi axis, University of Medical Sciences campus, Faculty of Paramedical Sciences
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5374 farsinezhad239@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Women between 20 and 45 years old Having poor or diminished ovarian reserve and having one of the criteria for poor ovarian response, which are: total number of Antral Follicles Count in both ovaries 7 or less on vaginal ultrasound, AMH less than 1.1 ng/ml, history of IVF with 3 or fewer eggs Reading and signing the informed consent form 20 years 45 years Female Pregnancy History or current IgA deficiency History of surgery leading to pelvic adhesions Taking anticoagulant medications Mental illness with dependence on drug use Chronic malignancies or chronic pelvic pain Infertility due to severe male factor Drug addiction Endometriosis and abnormal uterine shape observed in hysterosalpingogram Failure to sign the informed consent form 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 Condition Medium of mesenchymal stem cells derived from umbilical cord 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 Condition Medium of mesenchymal stem cells derived from umbilical cord in 1 stage into the ovaries of DOR patients under mild anesthesia with ultrasound guidance Control group: No injection Anti Mullerian Hormone. Timepoint: before injection and 2, 6 and 14 weeks after injection. Method of measurement: ELISA KIT. Antral Follicle Count(AFC). Timepoint: before injection and 2, 6 and 14 weeks after injection. Method of measurement: Vaginal ultrasound. Kerman University of Medical Sciences Approved 2024-11-25 Ethics committee of Kerman University of Medical Sciences Somayeh Intersection (Tahmaseb Abad), Beginning of Jihad Boulevard, Beginning of Ibn Sina Street Kerman Kerman Iran (Islamic Republic of)