Patients with Diminished ovarian response (DOR)have a poor in vitro fertilization(IVF) outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown promise in treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human Amniotic Mesenchymal Stem Cells(hAMSCs) in women suffered from infertility caused by DOR.
Patients with Diminished ovarian response (DOR)have a poor in vitro fertilization(IVF) outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown immense promise in the treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human amniotic mesenchymal stem cells(hAMSCs) in women suffered from infertility caused by DOR. The hAMSCs were isolated and cultured in vitro and qualified by National Institutes for Food and Drug Control, China. The serum of each patient was kept and sent for laboratory test before the transplantation. The biomarkers of hAMSCs were detected again before transplantation. The hAMSCs were transplanted via venous in the dorsum of hand. The outcomes of patients were examined during and after the injection. The patients are monitored for hormones, follicles stimulated with minimal stimulation, number of oocyte retrieval and embryos In Vitro Fertilization (IVF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
hAMSCs injection via venous in the dorsum of hand
Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Safety and tolerability after hAMSCs injection.
Safety and tolerability assessed by Adverse Events and serious during injection and adverse events (SAEs) after injection assessed by long term follow-up .
Time frame: Up to 12 months after first hAMSCs injection
The ratio of transplantable embryo in DOR patients after hAMSCs injection.
The ratio of transplantable embryo to normal fertilized embryos in DOR patients after hAMSCs injection.
Time frame: Up to 12 months after first hAMSCs injection
Ovarian function in DOR patients after hAMSCs injection.
Anti-müllerian Hormone (AMH) serum level, Follicle Stimulating Hormone (FSH) serum level, Estradiol (E2) serum level, Luteinizing Hormone (LH)serum level on menstrual day 2/3 will be evaluated after injection. The number of antral follicles will be recorded by transvaginal ultrasound scan.
Time frame: Up to 12 months after first hAMSCs injection
Outcomes of IVF in DOR patients after hAMSCs injection.
The number of oocyte retrieval, fertilization rate , blastocyst formation rate, implantation rate, incidence of clinical pregnancy rate, after hAMSCs injection.
Time frame: Up to 12 months after first hAMSCs injection
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