LOCAL: Prospective Multi-Center LOCALized Directional Insemination Trial for Artificial Insemination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Femasys Inc.
- 入组人数
- 314
- 试验地点
- 36
- 主要终点
- Primary Safety: Occurrence of uterine perforation per cycle
研究概览
简要总结
Brief Summary: The objectives of the trial are to evaluate the safety and effectiveness of the FemaSeed Localized Directional Insemination for artificial insemination, now known as the FemaSeed Intratubal Insemination since FDA Cleared under K231730 in September 2023.
详细描述
314 subjects enrolled (signed inform consent) inclusive of 188 subjects in protocol versions 1-4 and 126 subjects in protocol version 5 (including re-consented subjects).
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
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 19-40 years of age, with no tubal, uterine or ovarian infertility factor (including patent fallopian tubes with no evidence of hydrosalpinx)
排除标准
- •Greater than three prior intrauterine insemination (IUI) cycles
- •Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes)
- •Prior history of ectopic pregnancy or tubal surgery
结局指标
主要结局
Primary Safety: Occurrence of uterine perforation per cycle
时间窗: At time of procedure
Occurrence of uterine perforation per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in uterine perforation.
Confirmed pregnancy rate at approximately 3 weeks following FemaSeed procedure.
时间窗: 3 weeks
Confirmed pregnancy rate per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in pregnancy.
Primary Safety: Occurrence of ectopic pregnancy per cycle
时间窗: 7 weeks
Occurrence of ectopic pregnancy per cycle: defined as the proportion of cycles with one intrauterine insemination with FemaSeed that result in a definitively confirmed ectopic pregnancy (based on current accepted clinical standards)
次要结局
未报告次要终点