Status:
RECRUITING
Intra-ovarian Injection of MSC-EVs in Idiopathic Premature Ovarian Failure
Lead Sponsor:
Royan Institute
Conditions:
Premature Ovarian Failure
Eligibility:
FEMALE
20-38 years
Phase:
PHASE1
PHASE2
Brief Summary
Premature ovarian failure (POF) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. POF is characterized by menstrual disturbance (amenorrhea or oligomenorrhea) with...
Detailed Description
Investigating the effect of intraovarian injection of bone marrow-derived extracellular vesicles (MSC-EV) on serum levels of Follicle-Stimulating Hormone (FSH),Anti-Mullerian Hormone (AMH) levels, as ...
Eligibility Criteria
Inclusion
- 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
- Primary amenorrhea
- Congenital anomaly of the ovary
- Thyroid disease Immune system diseases such as lupus, etc.
- 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 study
Key Trial Info
Start Date :
February 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 18 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06202547
Start Date
February 20 2023
End Date
February 18 2025
Last Update
January 11 2024
Active Locations (1)
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1
Royan Institute
Tehran, Iran