Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Implantation Rate
研究概览
简要总结
The purpose of this study is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (IVF) while using minimal stimulation protocols
详细描述
This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal culture (IVC) using INVOcell versus traditional In-Vitro Fertilization (IVF) using oral stimulation or minimal gonadotropin stimulation protocols. The pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (N=20) using INVOcell or to the traditional IVF group (N=20).
Primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred.
Secondary aims are:
- Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of "Good", "Fair" or "Poor".
- Fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. This comparison will take place on day-3, as that is when the IVC embryos will be assessed.
- Clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred.
- Live birth rate, which is defined by the number of living babies delivered divided by the number of transfers
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
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal uterine cavity
- •One or more years of infertility
- •Normal male partner semen analysis
排除标准
- •Age <18 years old or >37 years old
- •Antral Follicle Count (AFC) <8
- •Abnormal male partner semen analysis or use of donor sperm
- •Vaginal inflammation or genital (vaginal, uterine, tubal) infection
- •Uncontrolled chronic disease (such as uncontrolled diabetes or hypertension)
- •Uterine anatomic abnormalities
- •Allergy to plastics or inability to use diaphragm retention device
- •Untreated hydrosalpinx
- •Current alcohol abuse (defined by >14 drinks/week)
- •Prior history of IVF cycle where fertilization did not occur
- •History of recurrent pregnancy loss
结局指标
主要结局
Implantation Rate
时间窗: approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age
defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred
次要结局
- Embryo Quality(measured after 3 days of incubation)
- Fertilization Rate(measured after 3 days of incubation)
- Live Birth Rate(9 months after embryo transfer)
- Clinical Pregnancy Rate(approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age)