Investigating the effect of intraovarian injection of extracellular vesicles derived from bone marrow mesenchymal stromal cells in patients with premature ovarian failure.

Safety and feasibility study of intra-ovarian injection of bone marrow mesenchymal stromal cells-derived extracellular vesicles in idiopathic premature ovarian failure patients: Clinical trial phase I

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20080831001141N43

Enrollment

Registered

2023-10-17

Start date

2023-02-20

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Premature ovarian failure. Primary ovarian failure

Interventions

Intervention group: The patient is anesthetized and placed in a lithotomy position, after preparing and washing the vagina with normal saline, under transvaginal ultrasound guidance (Aloka-40000 vagin

Eligibility

Sex/Gender

Female

Age

20 Years to 38 Years

Inclusion criteria

Inclusion criteria: Women between 20-38 years old Baseline serum level of follicle stimulating hormone (FSH) higher or equal to 25 IU/l at least twice with an interval of 3 or 4 months At least one year has passed since secondary amenorrhea and premature ovarian failure (POF) diagnosis Normal karyotype and fragile X messenger ribonucleoprotein 1 (FMR1) gene

Exclusion criteria

Exclusion criteria: Primary amenorrhea Congenital anomaly of the ovary Thyroid disease Immune system diseases such as lupus and... Previous and/or family history of ovarian tumor Previous and/or family history of suffering from major diseases in the past and present such as cancer Positive serological evidence regarding previous or current hepatitis B and C, Human T-lymphotropic virus 1, Human immunodeficiency virus (HIV), Syphilis Disturbance in the normal range of laboratory tests as levels of Hemoglobin Subunit Alpha 1 (HbA1), Alanine transaminase (ALT), The aspartate aminotransferase (AST), the number of white blood cells (WBCs), The creatinine (Cr), International normalised ratio (INR) , Platelets (Plt), Hematocrit (Hct) tests. History of specific systemic disease (rheumatology, endocrine, cardiovascular, etc.) Severe endometriosis (stage III and IV) Small and non-injectable ovaries Lack of patient satisfaction The patient's unwillingness to continue participating in the plan

Design outcomes

Primary

Measure	Time frame
Ovary abscess. Timepoint: First 24 hours, first week and monthly up to 8 months after injection. Method of measurement: Evaluation of ovarian abscess or any other ovarian lesion formation up to 8 months after intraovarian injection of extracellular vesicles derived from bone marrow mesenchymal stromal cells (any adverse events through follow-up visits (first 24 hours and first week after transplantation, 1, 2, 3, 4, 5, 6, 7 and 8 months after injection) will be checked and recorded.	—

Measure

Time frame

Ovary abscess. Timepoint: First 24 hours, first week and monthly up to 8 months after injection. Method of measurement: Evaluation of ovarian abscess or any other ovarian lesion formation up to 8 months after intraovarian injection of extracellular vesicles derived from bone marrow mesenchymal stromal cells (any adverse events through follow-up visits (first 24 hours and first week after transplantation, 1, 2, 3, 4, 5, 6, 7 and 8 months after injection) will be checked and recorded.

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Secondary

Measure	Time frame
Basal follicle-stimulating hormone (FSH) serum level. Timepoint: Baseline,1 week as well as one, two, three, four , five, six, seven and eight months after transplantation. Method of measurement: Laboratory test.;Serum anti-mullerian hormone (AMH) levels. Timepoint: Before the intervention (baseline) and also three, six and eight months after transplantation. Method of measurement: Laboratory test.;Menstruation recurrence rate. Timepoint: one, two, three, four , five, six, seven and eight months after transplantation. Method of measurement: Through monthly follow-up and asking the questions.	—

Measure

Time frame

Basal follicle-stimulating hormone (FSH) serum level. Timepoint: Baseline,1 week as well as one, two, three, four , five, six, seven and eight months after transplantation. Method of measurement: Laboratory test.;Serum anti-mullerian hormone (AMH) levels. Timepoint: Before the intervention (baseline) and also three, six and eight months after transplantation. Method of measurement: Laboratory test.;Menstruation recurrence rate. Timepoint: one, two, three, four , five, six, seven and eight months after transplantation. Method of measurement: Through monthly follow-up and asking the questions.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh Shekari

Royan Institute

faezehshekari@gmail.com009821223562724

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026