The goal of this study is to determine safety and tolerability and of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure and to study the preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.
In this study 9 patients with the diagnosis of premature ovarian failure will participate. The patients will be divided randomly in 3 groups, each group contains 3 patients. First group will receive 5 millions of ADSCs, second group receive 10 millions cells and the third group receive 15millions of ADSCs. Stem cell Transplantation method is intraovarian injection of ADSCs which will be performed under guidance of transvaginal sonography. All the patients will be followed for 12 months after cell injection to evaluate any adverse events .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
Royan Institute
Tehran, Iran
RECRUITINGovary mass
Evaluation the formation of ovary mass by sonography up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
Time frame: up to 12months
ovary abcess
Evaluation the ovary abcess formation up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
Time frame: Up to 12 months
Follicle Stimulating Hormone (FSH) serum level
one year after transplantation (patient will follow for any adverse event via one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Time frame: Up to 12months
Anti-Mullerian Hormone (AMH) serum level
Evaluation the AMH serum level by blood sampling up to one year after transplantation (patient will follow for any adverse event via one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Time frame: Up to 12months
Number of antral follicle
Evaluation the number of antral follicle by sonography up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Time frame: Up to 12months
Antral follicle volume
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Evaluation the antral follicle volume by sonography up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Time frame: Up to 12months
Menstruation recurrence rate
Evaluation the menstruation recurrence rate up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Time frame: Up to 12 months
Pregnancy rate
Evaluation the pregnancy rate up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Time frame: Up to 12months