IRCT20080831001141N43
Recruiting
Phase 1
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
otus Royan Charitable Fundation0 sites10 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Premature ovarian failure.
- Sponsor
- otus Royan Charitable Fundation
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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