Utility of Fallopian Tube Cocultures in Assisted Reproductive Technology
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of participants with good embryo quality as a measure of efficacy
研究概览
简要总结
Prospective Feasibility Study:
Fallopian tube cells will be obtained from patients undergoing laparoscopic surgery during their surgical evaluation of infertility. Of note, these patients are already scheduled to undergo surgery as part of their standard of care.
详细描述
The surgical technique will involve laparoscopic brush and tissue biopsies of the fallopian tube lumen. A small piece of the fallopian tube lining will be removed during the surgery.The biopsy is a minimally invasive and relatively pain free procedure. Co culture blood serum will be drawn at least one day prior to the biopsy and during the IVF cycle. The fallopian tube sample is sent to the Center for Reproductive Medicine (CRM) lab where it is treated, purified and frozen. The next month or whenever the physician deems appropriate, the patient will then undergo a typical IVF cycle and will be given standard medication protocol determined by her physician to stimulate egg growth in her ovaries. The patient's eggs will be retrieved and mixed with sperm. At this time, the lab will begin to thaw and grow the fallopian tube cells. Once fertilization is confirmed, the patient's embryos will be placed on top of her own (now thawed) fallopian tube cells and allowed to grow. Subsequently, the embryos will be placed on top of her uterus for implantation and pregnancy.
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
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing assisted reproductive technology at Weill Cornell Medical College (WCMC) and are scheduled to undergo surgery as part of their standard of care
- •Women who had a prior failed IVF cycle
- •Women with normal Hysterosalpingogram (HSG) or a prior laparoscopy confirming normal tubal status
- •Both the patient (potential subject) and her partner must sign the consent form
排除标准
- •Pregnancy
- •Undiagnosed vaginal bleeding
- •Fallopian tube disease
结局指标
主要结局
Number of participants with good embryo quality as a measure of efficacy
时间窗: 8 weeks
The outcomes measures for embryo quality will include an assessment of the embryo grade, embryo fragmentation rates, implantation rates and pregnancy rates.
次要结局
- Number of participants with Adverse Events as a measure of Safety and Tolerability(8 weeks)