The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian Malignancy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- the volume of ovary(cm*cm*cm)
研究概览
简要总结
The design of this prospective interventional study is to investigate the clinical significance of applying GnRHa preoperatively and postoperatively and detecting physical and endocrinic change in fertility preservation surgery
详细描述
20 patients with ovarian maligancies are anticipated to be enrolled in this study within 2 years. With their permission, they will be randomized into the control group and the experimental group when the latter is supposed to receive GNRHa preoperatively and postoperatively. And their physical and endocrinic indexes will be monitored. The effect of extra use of GnRHa will be observed by comparing these two groups' outcomes.
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
- 1 Year 至 90 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in the study with informed consent;
- •Females aged 10-90 who are confirmed with ovarian malignancy and are willing to receive GnRHa experimentally to preserve their fertility function.
排除标准
- •Pregnancy, lactation and postmenopause;
- •Suspected or identified as other tumors of genital tract;
- •History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
- •Other diseases or heavy injuries that will interfere with the results;
- •Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
研究组 & 干预措施
group 2
干预措施: GnRHa (Drug)
结局指标
主要结局
the volume of ovary(cm*cm*cm)
时间窗: 1 year during the perioperative period
by monitoring the change of ovarian form and volume, we evaluate the physical ovarian transformation
the ovulating period
时间窗: 1 year during the perioperative period
by comparing the ovulating period perioperatively and postoperatively between two groups, we assess the GnRHa effect on the reproductive function
the content of FSH(mIU/mL), LH(mIU/mL), E2(pmol/L), P(nmol/L), T(nmol/L) and PRL(nmol/L)
时间窗: 1 year during the perioperative period
by monitoring six above-mentioned hormones preoperatively and postoperatively, the ovarian function is evaluated
次要结局
未报告次要终点