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IRCT20251118068036N4 IRCT 2026-06-11 Hamedan University of Medical Sciences Studying the effect of mesenchymal stem cell exosomes on infertility treatment in patients with poor ovarian response (POR). Investigating the effect of using mesenchymal stem cell exosomes in the treatment of infertility in patients with Poor Ovarian Response 2026-05-13 anticipated 30 Recruiting https://irct.ir/trial/89578 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method was clarified in the study protocol as follows: Participants were allocated to two intervention and control groups in a 1:1 ratio using a block randomization method. The random sequence was generated using Random Allocation Software and the blocks were considered as 4 and 6 variables. The allocation sequence was kept by an independent person from the study team in sealed, numbered, and opaque envelopes to ensure allocation concealment. Also, in the control group, a placebo with the same appearance and administration method as the main intervention was used. In the control group, the placebo (PBS solution without exosome) with the same appearance, volume, and administration method as the main intervention was received intraovarianly, Blinding description: This study will be conducted in a single-blind manner. In this regard, patients (participants) will be unaware of the type of drug they receive (exosomes or placebo). Also, the person responsible for evaluating the outcomes and collecting clinical data will be unaware of the patient grouping (intervention or control). This is done to reduce bias due to knowledge of the type of treatment received in the study results. It should be noted that due to the nature of the intervention, researchers who directly prescribe the intervention will be aware of the patient grouping. 1 Investigating the effect of using mesenchymal stem cell exosomes in the treatment of infertility in patients with Poor Ovarian Response (POR). Intervention 1: Intervention group: This group includes patients who are treated with mesenchymal stem cell exosomes.Number: 15 eligible patients who receive exosomes (100-200 micrograms of protein) intravaginally.Duration of treatment: One treatment followed by follow-ups 1 month later and 3-6 months after injection. Intervention 2: In order to maintain blinding of the study, a phosphate buffered saline (PBS) solution, which does not contain any exosomes, is used for the control group patients. This solution is prepared exactly the same as the original product in terms of its appearance (color and transparency), injection volume (completely similar to the volume of the exosome solution), and administration method (intraovarian injection under ultrasound guidance via the transvaginal route).All placebo solutions are prepared and standardized by the Research Center's Biological Products Production Unit under sterile conditions and under the supervision of the Quality Control Unit, and are delivered to the infertility clinic on the same day of the intervention. Yes - There is a plan to make this available What will be shared: Access to data will be available immediately after the final article is published. When: Access to data will be available immediately after the final article is published To whom: All researchers, researchers and clinical experts will be allowed to access the data of this study. Conditions: It will be welcomed to conduct extensive analysis on the data of this study along with the data of other studies to write meta-analysis review articles. Where to obtain: For more information, please send an email to Dr. Mahnaz Yavangi. All correspondence will be addressed to yavangi@umsha.ac.ir How to obtain: After making a phone call and submitting a request via email, a final response will be sent within at least 1 month. Comments:
public Mahnaz Yavangi
Shahid Fahmideh St
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3131 0000 yavangi@umsha.ac.ir Hamedan University of Medical Sciences scientific Mahnaz Yavangi
Shahid Fahmideh St
Hamadan Iran (Islamic Republic of) 657838678 +98 81 3131 0000 yavangi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Diagnosis: Women with Poor Ovarian Response (POR) History of infertility: At least one year of infertility history Consent: Obtaining written consent from patients. 20 years 35 years Female Age less than 20 or more than 35 years old History of infertility for less than one year N97 Female infertility Treatment - Drugs Treatment - Drugs Intervention group: This group includes patients who are treated with mesenchymal stem cell exosomes.Number: 15 eligible patients who receive exosomes (100-200 micrograms of protein) intravaginally.Duration of treatment: One treatment followed by follow-ups 1 month later and 3-6 months after injection. In order to maintain blinding of the study, a phosphate buffered saline (PBS) solution, which does not contain any exosomes, is used for the control group patients. This solution is prepared exactly the same as the original product in terms of its appearance (color and transparency), injection volume (completely similar to the volume of the exosome solution), and administration method (intraovarian injection under ultrasound guidance via the transvaginal route).All placebo solutions are prepared and standardized by the Research Center's Biological Products Production Unit under sterile conditions and under the supervision of the Quality Control Unit, and are delivered to the infertility clinic on the same day of the intervention. Pregnancy. Timepoint: 3 to 6 months after exosome injection. Method of measurement: Transvaginal ultrasound or assessment of return of menstrual cycle. Serum anti-Mullerian hormone (AMH) levels. Timepoint: Before treatment and 3 to 6 months after injection. Method of measurement: blood test. Hamedan University of Medical Sciences Approved 2026-03-14 Research Ethics Committee of Hamadan University of Medical Sciences Shahid Fahmideh Street Hamadan Hamadan Iran (Islamic Republic of)