Controlled Ovarian Stimulation and Human Uterine Lavage: A Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Serious Adverse Event Collection
研究概览
简要总结
This is a feasibility study intended to demonstrate the Previvo Uterine Lavage System's ability to recover embryos from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
详细描述
The study is a prospective, multi- center, multiple-arm, feasibility study to evaluate the safety and efficacy of the Previvo System in the recovery of embryos.
This study will recruit up to 500 healthy premenopausal volunteers. Subjects will undergo either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI) and have the lavage procedure performed 4-6 days post IUI. It is anticipated that embryos recovered will be cryopreserved for future use or donated for future use.
Subjects will be followed up with for up to 30 days after the lavage procedure. All data will be collected on paper CRFs and analyzed by the Principal Investigator and Study Sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal female 18-40 years of age
- •Physically healthy and reasonably healthy family medical history
- •Having both ovaries with patent fallopian tubes, no known reproductive problems
- •BMI between 18-35 Kg/m2
- •Presence of a normal uterine cavity as assessed by sonohysterogram (SHG), hysterosalpingogram (HSG), or ultrasound
- •Evidence of normal uterine anatomy that would not prevent the introduction of the lavage catheter.
排除标准
- •History of, or presence of hydrosalpinx
- •Addiction to alcohol and/or narcotics
- •Had radiotherapy or chemotherapy
- •Existence of an ovarian cyst at the beginning of cycle with suspicion of malignancy or a large benign cyst
- •Contraindication for oral contraceptive pills or other study medication
- •Clinically significant abnormal basic metabolic panel lab results
- •Positive test or history of any of the following conditions:
- •Human immunodeficiency virus (HIV)
- •Hepatitis B infection
- •Hepatitis C infection
- •Syphilis (RPR)
- •Chlamydial pelvic infection
- •Gonorrheal pelvic infection.
- •Positive Pregnancy Test
- •Prior IUD for 60 days or less, or one currently in place
- •Allergic to study materials, supplies and medication
- •Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator
研究组 & 干预措施
Uterine Lavage
Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
干预措施: Uterine lavage (Procedure)
结局指标
主要结局
Serious Adverse Event Collection
时间窗: 30-Days
Assessment of pain during procedure, bleeding experienced during procedure, and infection symptoms experienced subsequent to procedure. Assessment of fluid recovery, fluid loss through cervix, fluid accumulation in the uterus and fluid loss through fallopian tubes.
次要结局
- Recovery of Embryos(1 Day)