Vitrified Ovarian Tissue in Cancer Patients: Assessing the Technique in Vietnam
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Rate of Survivable follicle
研究概览
简要总结
Ovarian tissue cryopreservation (OTC) is a new approach on fertility preservation for young female patients with cancer. It is now used by many IVF centers in the world. However, this is the first study which OTC by vitrification is carried on and assessed the effectiveness of the technique.
详细描述
Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy will be enrolled to the study. Pieces of cortex of each patient will divide into two groups. Group 1 is fresh fragments (control group) and group 2 is vitrified group. Ovarian tissues in group 2 will be vitrified or warmed with medium and devices of Ova-kit type M (Kitazato, Japan).
Cortex fragments of each group will have:
- Follicle survival evaluation by Neutral red staining
- Histological evaluation by Hematoxylin and Eosin staining
- Evaluation relative Growth Differentiation Factor 9 (GDF-9) and Caspase-3 gene expression by real-time Polymerase chain reaction (PCR).
Comparison of data collected from 2 groups will be carried on to evaluate the effectiveness of the technique before applying this technique for cancer patients in Vietnam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy
排除标准
- •The volume of ovaries is less than 2/3 of normal 3cm (L) x 2.5cm (H) x 1.5cm (W) ovary.
结局指标
主要结局
Rate of Survivable follicle
时间窗: After 4 hours stained by Neutral red
Percentage of survivable follicles per counted follicles in one fragment
次要结局
- Rate of Healthy follicle by histological analysis(Immediately after tissue stained by Hematoxylin and Eosin)
- The relative expression ratio ( R ) of genes in follicles(Immediately after the intervention)