The Safety and Efficacy Assessment of Human Amniotic Mesenchymal Stem Cells(hAMSCs) Transplantation in Woman With Diminished Ovarian Reserve (DOR)
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety and tolerability after hAMSCs injection.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between35 and 45 years, who is diagnosed with Diminished Ovarian Reserve by Bologna criteria, (AFC≤7，or serum AMH level < 1.10ng/ml), and failed pregnancies in at least two cycles of In Vitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI).
- •Willing to sign the Informed Consent Form.
排除标准
- •Patients diagnosed with hereditary, immunological and iatrogenic premature ovarian failure
- •Patients allergy to blood products
- •Patients diagnosed with abnormal coagulation function
- •Patients diagnosed with uterine malformation
- •Patients undergoing Preimplantation Genetic Testing
- •Patients diagnosed with hydrosalpinx
- •Patients diagnosed with infectious diseases
- •Contraindications for In Vitro Fertilization-Embryo Transfer(IVF-ET) or pregnancy
- •Prior personal history of stem cell clinical trail or other clinical trails
- •Unwilling to comply with study protocol
- •Patients identified with high risk for stem cell injection
结局指标
主要结局
Safety and tolerability after hAMSCs injection.
时间窗: Up to 12 months after first 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 .
The ratio of transplantable embryo in DOR patients after hAMSCs injection.
时间窗: Up to 12 months after first hAMSCs injection
The ratio of transplantable embryo to normal fertilized embryos in DOR patients after hAMSCs injection.
次要结局
- Ovarian function in DOR patients after hAMSCs injection.(Up to 12 months after first hAMSCs injection)
- Outcomes of IVF in DOR patients after hAMSCs injection.(Up to 12 months after first hAMSCs injection)