Sperm Micro-swim up; a Novel Technique to Process and Select in the Same Dish:a Sibling-oocyte-split Design)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Number of top quality embryos
研究概览
简要总结
A sibling-Oocyte-split design will be conducted on oocytes before denudation and divided into two groups : control group (MII oocytes will be injected using sperm processed by Density gradient method) and sample group ( MII oocytes will be injected by sperm processed using micro-swim up technique)
详细描述
In This study investigators compare a novel sperm processing and selection method which is (fast, cheap and safe) with the well known processing method of sperm "Density gradient (DG)"
The dishes will be prepared with droplets of handling medium for oocytes (droplet volume 10 μL), and an H pattern using PVP will be produced, finally, all the droplets will be overlaid with mineral oil.
Control group : Oocytes will be injected using sperm after processing with DG and will be selected from control PVP microdroplets
Sample group: Sperm will be directly loaded in specific ICSI dishes where is the PVP microdroplets is prepared on "H" Pattern and will be selected from the far point from the deposition point and will be injected into the oocytes from the sample group All injected MII oocytes from both groups will then be cultured, with each group demarcated in separate place in the culture dish then according to the randomisation embryo transfer will be selected from one of both groups then the quality of the embryos will be reported and the pregnancy rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
the oocytes of each patient will be randomly divided before denudation and will be distributed in the ICSI dishes of different previously described PVP pattern and sperm processing
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The normal & high responders were selected according to :
- •age: 18 - 40 years
- •anti-Müllerian hormone (AMH): > 1.0 ng/ml
- •number of aspirated oocytes:more than or equal 8
- •BMI < 34
排除标准
- •Age > 40 years;
- •AMH < 1.0 ng/mL;
- •aspirated oocytes <
- •severe male factor
- •Testicular aspirated sperm
结局指标
主要结局
Number of top quality embryos
时间窗: 4 or 5 days after ICSI procedure day
the number of best embryos in each arm in Day 4 or Day 5
次要结局
- chemical pregnancy rate(14 days after embryo transfer day)
- Early Cleavage rate(2 days after ICSI procedure day)