Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Embryo development rate
研究概览
简要总结
The purpose of this study is to investigate the potential of autologous adipose stem cell (ASC) mitochondrial transfer (ASCENT) to oocytes along with intracytoplasmic sperm injection (ICSI)as a means of enhancing embryo development and improving the success rate of in patients with a history of multiple IVF failures. Embryo quality plays a crucial role in determining the success of assisted reproductive technologies and directly contributes to repeated pregnancy failures. Several factors, including age, physiological conditions, genetics, and environmental influences, can significantly impact embryo quality. Oocytes, the largest cells in the human body, are heavily reliant on mitochondria. Mitochondria's role in providing energy for oocytes is crucial, and insufficient energy production has been linked to poor oocyte and embryo quality. Some human studies have shown that increasing oocyte mitochondrial mass can improve embryo quality in patients who have experienced repeated IVF failures.
详细描述
Sibling mature oocytes will be randomly divided into two groups. And one group of oocytes will be undergone conventional intracytoplasmic sperm injection (ICSI) (control group; cont. ICSI) and the other group of oocytes will be undergone mitochondria transplantation along with intracytoplasmic sperm injection (Mito-ICSI). Viable blastocysts from both groups will be biopsied for preimplantation genetic testing for aneuploidy.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 29 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having at least three previous failed IVF trial
- •Specifically consented for to collect biopsies for Preimplantation generic testing for aneuploidy (PGTA) analysis
- •Specifically consented for to have single blastocyst transfer (recommended)
- •No major uterine or ovarian abnormalities
- •Specifically consented for to have all embryos frozen
- •Specifically consented for to collect adipose tissues from subcutaneous liposuction
- •BMI level level <26kg/m2
排除标准
- •Ovarian endometriosis with Chocolate cysts (American Fertility Society (AFS)) classification type 3 and 4
- •Any medical contraindication oocyte retrieval or subsequent procedures Ovarian hyperstimulation syndrome Bleeding disorders Sex hormone allergies Severe emotional defect on injections
- •Severe sperm abnormalities
- •<5 million/mL motile sperm
- •Uterine structural anomalies
- •Polycystic ovaries
- •Premature ovarian failure
结局指标
主要结局
Embryo development rate
时间窗: Up to 8 weeks post-intervention
Analyze and compare the transferable embryo rate per zygote on day 3 \& day 5 between the Intervention and control groups.
次要结局
- Ongoing clinical pregnancy rate after the first transfer(Up to 18 months post-intervention)
- Chemical pregnancy rate(Up to 18 months post-intervention)
- Live Birth rates(Up to 24 months post-intervention)
- Pregnancy complication(Up to 24 months post-intervention)
- Abortion rate(Up to 24 months post-intervention)
- Additional in vitro fertilization - outcome indicators(Up to 8 weeks post-intervention)