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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251118068036N2

Enrollment

Registered

2026-05-16

Start date

2026-05-13

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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). Primary ovarian failure

Interventions

Intervention 1: Intervention group: Treatment type: Intraovarian injection of mesenchymal stem cell-derived exosomes (MSC-Exosomes).Technical details:Exosomes are prepared from mesenchymal cells extra

Eligibility

Sex/Gender

Female

Age

25 Years to 40 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahnaz Yavangi

Hamedan University of Medical Sciences

yavangi@umsha.ac.ir+98 81 3131 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026