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IRCT20251118068036N2 IRCT 2026-05-16 Hamedan University of Medical Sciences Effects of exosomes on premature menopause and return of menstruation in POF patients Evaluation of the effects of exosome therapy on the return of menstrual cycles and improvement of premature menopause symptoms in patients with premature ovarian failure (POF) 2026-05-13 anticipated 18 Recruiting https://irct.ir/trial/89579 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants will be assigned to two intervention (exosome) and control (PRP) groups using a 1:1 block randomization. To avoid predictability of allocation, blocks of variable size (4 and 6) will be used. The randomization sequence will be prepared by statistical software and by an individual independent of the treatment team. The randomization unit in this study is the individual and each participant will be individually allocated to one of the two groups. For allocation concealment, opaque, closed, sealed and numbered envelopes will be used in the order of arrival. These envelopes will only be opened at the time of allocation and after the patient has been definitively entered the study to avoid selection bias, Blinding description: The study will be conducted in a single-blinded manner; that is, the outcome assessor will be unaware of the group allocation of patients. Given the intrinsic differences between exosome and PRP interventions, blinding of the participant and the intervention provider is not possible. Patient allocation will be coded and performed using sealed envelopes. 2 Evaluation of the effects of exosome therapy on the return of menstrual cycles and improvement of premature menopause symptoms in patients with premature ovarian failure (POF). Intervention 1: Intervention group: Treatment type: Intraovarian injection of mesenchymal stem cell-derived exosomes (MSC-Exosomes).Technical details:Exosomes are prepared from mesenchymal cells extracted from Wharton’s Jelly tissue.Cells are cultured at passages 3 to 5 and exosomes are separated from the supernatant by ultracentrifuge.Purified exosomes are stored in PBS at -80°C until use.Administration: Intraovarian injection (by a gynecologist in an infertility clinic). Intervention 2: Control group: In this group, autologous platelet-rich plasma (PRP) is used as a comparative intervention. PRP is prepared from the subject's own venous blood sample and, after processing by centrifugation, is injected intraovarianly under transvaginal ultrasound guidance. The injection volume, frequency, and details of PRP preparation will be determined according to the study protocol. 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 further information
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) Definitive diagnosis of POF/POI: High FSH levels (usually greater than 25 or 40 IU/L on two occasions one month apart) and low estradiol levels. Ovarian reserve: The presence of a minimum number of antral follicles (AFC) on ultrasound. informed consent 25 years 40 years Female Genetic or chromosomal causes: The presence of syndromes such as Turner Syndrome or specific mutations that are the main cause of ovarian failure. Underlying diseases: Active autoimmune diseases, hormone-dependent cancers, or severe systemic diseases (heart, kidney, liver). E28.3 Primary ovarian failure Treatment - Drugs Treatment - Drugs Intervention group: Treatment type: Intraovarian injection of mesenchymal stem cell-derived exosomes (MSC-Exosomes).Technical details:Exosomes are prepared from mesenchymal cells extracted from Wharton’s Jelly tissue.Cells are cultured at passages 3 to 5 and exosomes are separated from the supernatant by ultracentrifuge.Purified exosomes are stored in PBS at -80°C until use.Administration: Intraovarian injection (by a gynecologist in an infertility clinic) Control group: In this group, autologous platelet-rich plasma (PRP) is used as a comparative intervention. PRP is prepared from the subject's own venous blood sample and, after processing by centrifugation, is injected intraovarianly under transvaginal ultrasound guidance. The injection volume, frequency, and details of PRP preparation will be determined according to the study protocol. Menstrual Cyclicity: Percentage of patients who show regular or significant return of menstruation during the follow-up period (3 to 6 months after injection). Timepoint: Measurements will be taken at the beginning of the study (before treatment), the second month (ultrasound), the third month (hormones, ultrasound, menstruation, pregnancy), the fourth month (ultrasound), and the sixth month (hormones, ultrasound, menstruation, pregnancy). Method of measurement: Patient-reported outcome recording and confirmation by the physician based on observation of bleeding pattern and cycle regularity. Spontaneous or Clinical Pregnancy Rate: The percentage of patients who become pregnant during the study period (and up to 6 months after injection). Timepoint: Follow-up in the third and sixth months. (If pregnancy symptoms appear earlier, an evaluation will be done at the appropriate time). Method of measurement: Positive serum beta hCG test (≥25 IU/L) and confirmation of clinical pregnancy by visualization of the gestational sac via ultrasound. AMH hormone level. Timepoint: AMH levels, as a secondary outcome, will be measured at three time points: baseline (before intervention), three months after intervention, and six months after intervention, using blood samples and ELISA. The unit of measurement is nanograms per milliliter (ng/mL). Method of measurement: After serum separation, the venous blood sample is stored at -80°C and then measured using an ELISA kit (the name of the kit should be mentioned if known). The final results will be reported in nanograms per milliliter (ng/mL). Levels of FSH, LH, and estradiol (E2) hormones. Timepoint: It will be measured at three time points, including the beginning of the study (before the intervention), three months after the intervention, and six months after the intervention, using a blood sample and ELISA method. The unit of measurement is nanograms per milliliter (ng/mL). Method of measurement: Blood sample and ELISA-based assays - measured on days 3 to 5 of the cycle if the cycle returns. 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)