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临床试验/NCT01329302
NCT01329302已完成不适用

Follicular Flushing for Poor Responder Patient in an Assisted Reproductive Technology Program: Flush Study

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2011年3月1日最近更新:
适应症

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

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)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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