The Valve of Hyaluronic Binding Selection (PICSI) in Improving IVF Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- implantation rate
研究概览
简要总结
The investigators would like to assess whether selecting mature sperm using PICSI (selecting for sperm that bind hyaluronan) can optimize the IVF outcome of ICSI .
Aim
- Primary outcome: To compare routine sperm selection using ICSI with sperm selection using PICSI plates in terms of implantation and fertilization rates for couples with male factor fertility
- Secondary outcome : To compare live birth rates ,ongoing pregnancies and miscarriage rates for couples with male factor infertility using routine sperm selection with ICSI compared to using PICSI plates for sperm selection
Hypothesis:
Sperm selected for ICSI using (PICSI) will reveal increased implantation rates in comparison to sperm selected for conventional ICSI
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In order to participate in the study women must be 42 years old or younger and suffer from male factor infertility however they may have other causes for their infertility
- •male factor infertility as defined by one or more of the following sperm parameters: <20 Million /ml sperm concentration < 30% normal morphology < 3% Kruger morphology < 50% motility sion Criteria:
排除标准
- 未提供
研究组 & 干预措施
PICSI
PICSI dish ( MidAtlantic Diagnostics Inc) has been developed to select the specific sperm to be used for the ICSI procedure using the same principles as the Sperm Hyaluronan Binding Assay. HA-mediated ICSI sperm selection( PICSI) uses Falcon Petri dishes that feature three microdots of hyaluronan hydrogel attached to the interior bottom: mature, biochemically competent spermatozoa bind to hyaluronan, where they can be isolated and used for ICSI
干预措施: PICSI (Procedure)
ICSI
干预措施: PICSI (Procedure)
结局指标
主要结局
implantation rate
时间窗: 12 months
次要结局
- fertilization rate(12 months)