Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Device Retention
研究概览
简要总结
The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.
详细描述
This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days.
The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.
Primary Endpoint
• Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.
Secondary Endpoint
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have been informed about the study and have given their written consent.
- •Patients 18 years to 42 years
- •Women who are scheduled for an oocyte retrieval in anticipation of INVOcell IVF.
排除标准
- •Inability to read and speak English fluently
- •Identified vaginal infection
- •Recent pelvic surgery based on clinical history and physical examination.
- •History of toxic shock syndrome
- •Inability to tolerate the placement or wearing of the INVOcell IVC or INVOcell Retention Device.
- •Inability to tolerate a speculum examination
- •Unwilling or unable to wear the INVO Retention (diaphragm) during the incubation.
- •Unable or unwilling to sign informed consent or abide by study follow up assessment requirements.
结局指标
主要结局
Device Retention
时间窗: 5 days
The primary endpoint is INVOcell IVC retention with the Retention Device. The following will be assessed: Whether the INVOcell IVC stays in place (is retained within the vaginal cavity) while being used with the Retention Device during 5 days of continuous vaginal incubation.
次要结局
- Optical clarity(5 days)
- Comfort(5 days)
- Vaginal tissue reactions(5 days)