NCT07240779尚未招募不适用
Evaluating the Use of Advanced Sperm Selection Methods on ICSI Procedure Outcomes by Physiological Intracytoplasmic Sperm Injection (PICSI) Verses ZyMot Device
Sunrise Fertility Center0 个研究点目标入组 300 人开始时间: 2025年11月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Primary outcome measure
研究概览
简要总结
our study explores the effectiveness of two advanced sperm selection techniques-PICSI and the ZyMot microfluidic device-in improving outcomes of Intracytoplasmic Sperm Injection (ICSI). It aims to compare their impact on fertilization rates, embryo quality, and clinical pregnancy success, helping determine which method offers superior results in assisted reproductive technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age for women is between 20-39 years old.
- •Body mass index (BMI) between 19 kg/m and 35 kg/m
- •Normal Prolactin level.
- •No other endocrinological abnormality including thyroid disorder or diabetes.
- •With antimullerian hormone (AMH) at least 1.5 ng/ml, ), with normal progesterone level.
- •Primary or secondary infertility at least of 2 years duration.
- •No evidence of endometriosis.
- •No other medical or surgical disease.
- •The day of embryo freezing is the fifth day (day 5), and all patients who undergo the process of transferring frozen embryos.
- •The endometrium thickness is between 8-14 mm on day of transfer.
- •Inclusion criteria of male partner were; presence of ejaculate motile spermatozoa with total sperm number 1 million/ml at least and sperm motility 5% or more and all patient with high DNA fragmentation index above 35%.
排除标准
- •Women were older than 40 years of age or younger than 18 years old.
- •Women laparoscopically diagnosed to have endometriosis within the last 1 year.
- •Male infertility factor with immotile sperm.
结局指标
主要结局
Primary outcome measure
时间窗: 6-9 weeks after embryo transfer.
1• clinical pregnancy rate:- defined as the presence of a fetal heartbeat or gestational sac. • Unit of Measure: Percentage (%)
次要结局
- secondary outcome measure(1-After 6 weeks of gestation.)
研究者
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