Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 257
- 试验地点
- 2
- 主要终点
- the number of mature oocytes collected
研究概览
简要总结
The object of this study is to determine the benefit of follicular flushing with a double channel needle in a poor responder population for a maximum number of oocytes to be retrieved. The investigators compare two methods of oocyte retrieval with or without flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and more the day of ovulation induction will be included, following a randomized protocol in two groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G. Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all follicles are flushed with flushing solution in addition to direct aspiration of the follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing medium is collected separately from direct fluid aspiration in order to follow up each oocyte one by one. First criterion of our comparison is the number of oocyte retrieved. Second criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained, clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes collected in flush medium and oocytes from direct follicle fluid. Then the investigators will know the capability of oocyte collected after follicular flushing to be fertilized and to increase the success chance of pregnancy for poor responder patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 43 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients undergoing an IVF or ICSI treatment
- •long agonist, antagonist or short stimulations protocols
- •less than 5 follicles of 14mm or more day of HCG
- •Major patients aged under 43 years
- •patient within a couple married or can prove a married life of over 2 years
排除标准
- •all the cons indication to the oocyte retrieval
- •oocyte donor
- •Couple supported viral loop
- •Patient does not speak French or unable to give informed consent
- •Patients major protected
- •Patients with biopsy performed on weekends are also excluded due to unavailability of adequate personnel and equipment
- •Absence of follicles
结局指标
主要结局
the number of mature oocytes collected
时间窗: 2 years and 9 months
Increase the number of mature oocytes collected during the follicular flushing with a double lumen aspiration needle
quality of embryos obtained
时间窗: 2 years and 9 months
Embryo quality is assessed at the Laboratory of Reproductive Biology by a score based on: cell number, cell regularity and degree of fragmentation.
次要结局
- Number of transferable embryos (transferred and frozen)(2 years and 9 months)
- Number of pregnancies obtained(2 years and 9 months)
- Number of embryos obtained(2 years and 9 months)
