Intra-ovarian injection of stem cell-derived vesicles for premature ovarian failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of intra-ovarian injections of extracellular vesicles derived from mesenchymal stromal cells on women diagnosed with premature ovarian failure. The study aims to evaluate changes in hormone levels, specifically Follicle-Stimulating Hormone (FSH) and Anti-Mullerian Hormone (AMH), as well as the potential restoration of menstrual cycles over an 8-month follow-up period. A total of 10 eligible patients will receive the treatment, and their responses will be monitored for any side effects or complications. The trial is designed to provide insights into a novel therapeutic approach for this condition.

Why it matters

Who can join: the full rules

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, 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

Where it's running

• Royan Institute
  Tehran, Iran, Islamic Republic of Recruiting

Study contacts

• Principal investigator: Faezeh Shekari, Ph.D — Department of Development of Stem Cell Sciences of Royan Institute
• Study coordinator: Parvaneh Afsharian, Ph.D
• Email: p.afsharian@royan-rc.ac.ir
• Phone: +9802123562674

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.