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

Phase 1

Recruiting

Conditions: Premature ovarian failure.
Primary ovarian failure
E28.3

Registration Number: IRCT20080831001141N43

Lead Sponsor: otus Royan Charitable Fundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 10

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)
Small and non-injectable ovaries
Lack of patient satisfaction
The patient's unwillingness to continue participating in the plan

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.