Premature Ovarian Failure
Conditions
Keywords
Premature ovarian failure adipose derived stromal cells intraovarian injection
Brief summary
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.
Detailed description
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 .
Interventions
BIOLOGICALIntraovarian injection of Adipose derived Stromal cells (ADSCs)
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
Sponsors
Royan Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* female * Age : 20-39 * FSH\>20
Exclusion criteria
* liposuction contraindication * thyroid dysfunction * immune system disease * past history of cancer , chemotherapy , radiotherapy * HIV+, hepatitis B, C * Severe endometriosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovary mass | up to 12months | 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. |
| ovary abcess | Up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of antral follicle | Up to 12months | 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 |
| Antral follicle volume | Up to 12months | 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 |
| Follicle Stimulating Hormone (FSH) serum level | Up to 12months | 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 |
| Pregnancy rate | Up to 12months | 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 |
| Menstruation recurrence rate | Up to 12 months | 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 |
| Anti-Mullerian Hormone (AMH) serum level | Up to 12months | 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 |
Countries
Iran
Contacts
Primary ContactNasser Aghdami, MD, PhD
Backup ContactLeila Arab, MD
Outcome results
None listed