Phase 1 Study of the Impact of Injecting an Autologous Somatic Mitochondrial Concentrate Into Poor Quality Ova.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The rate pace and quality of the early embryonic development
研究概览
简要总结
A prospective randomized controlled trial (RCT) to determine the effect of injecting an autologous somatic mitochondria concentrate, together with the spermatozoon during ICSI, into oocytes of older and or poor prognosis in vitro fertilization (IVF) patients.
详细描述
Maternal age at first delivery constantly rises in developed countries. Oocyte quality decreases with advanced age, thus the rate of age-related infertility continuously increases. Presently oocyte donation is the only prompt solution for this widespread problem. Deterioration of mitochondrial function was suggested as one of the explanations for the age-related deterioration of oocyte quality. The supplementation of the ageing oocyte with autologous mitochondria from dividing somatic cells can be a possible solution for energetic enrichment, without introducing foreign mtDNA.
We established a non-hazardous clinical grade system to prepare functional autologous mitochondria concentrate from the granulosa cells aspirated during oocyte pick up. The mitochondrial preparation was examined and found to be non-toxic. The activity of the respiratory chain was constant and unaffected by age or ovarian response. Moreover, the mtDNA in the mitochondrial preparation was found to be intact in all samples examined, including those from older and low responding patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adequate sperm source and uterine cavity. And one or more of the following:
- •Age > 40
- •3 unsuccessful IVF cycles or
- •> 75% of embryos in previous cycles with > 20-50% fragments or
- •< 50% fertilization rate in previous cycles
排除标准
- •Inadequate sperm source. Inadequate uterine cavity.
结局指标
主要结局
The rate pace and quality of the early embryonic development
时间窗: up to 6 days
The rate (the proportion of fertilized oocytes developing into embryos), pace of cleavage, and quality (morphological) of the early embryonic development will be assessed during the next 1-6 days (case specific).
Oocyte fertilization rate
时间窗: one day
Fertilization rate is assessed the day following oocyte retrieval.
次要结局
- Clinical pregnancy(within 2 months)