in Vivo Activation of Ovarian Cortex in Premature Ovarian Insufficiency
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Depth of cuts and closeness to blood vessel
研究概览
简要总结
The OLIVA device will enable to perform shallow slashes on the ovarian cortex in patients undergoing oophorectomy. Prior to the resection of the ovary from the pedicle we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels and later.
详细描述
The OLIVA device is built of 5 parallel razor blades enclosed by protective cap
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Peri/menopausal women undergoing laparoscopic oophorectomy
排除标准
- •Women with ovarian malignancy
- •Women with polycystic ovarian syndrome
研究组 & 干预措施
ex vivo activation
'OLIVA device' in patients that undergo oophorectomy on the cortex of the removed ovary we will perform 5 parallel slashes 3 cm long.
this will be followed by investigation by the pathologist as to the depth of cuts.
干预措施: OLIVA device (Device)
in vivo activation
'OLIVA device' in patients undergoing oophorectomy before the resection from is pedicle on cortex of the ovary we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels.
干预措施: OLIVA device (Device)
POI OLIVA
'OLIVA device' in patients with premature ovarian failure and following safety data from arm 2 activation by ovarian slashing will be performed laparoscopically by closed cutting device (OLIVA). follow-up by sonography and hormonal markers of ovarian activity
干预措施: OLIVA device (Device)
结局指标
主要结局
Depth of cuts and closeness to blood vessel
时间窗: Up to 30 days after procedure
The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device
次要结局
- Proximity of cuts to blood vessel(Up to 30 days after procedure)
研究者
Ariel Revel
Principal investigator
Hadassah Medical Organization