The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
This study evaluates the effectiveness of a novel sperm-wash device designed to improve outcomes in intrauterine insemination (IUI) for couples with infertility. Traditional sperm preparation methods, such as density gradient centrifugation (DGC), are associated with elevated reactive oxygen species (ROS) levels and increased sperm DNA fragmentation, potentially compromising pregnancy rates. The new device aims to reduce these adverse effects by minimizing oxidative stress and preserving sperm DNA integrity.
In this prospective, randomized controlled trial, 120 couples will be allocated to either the intervention group using the new device or the control group using DGC. The primary outcome is the clinical pregnancy rate, while secondary outcomes include sperm DNA fragmentation. The study hypothesizes that the novel device will result in higher pregnancy rates and reduced DNA fragmentation compared to DGC. These findings may support its use as a more physiological approach to sperm preparation in fertility treatment.
详细描述
This is a prospective, randomized, open-label, parallel-controlled clinical trial conducted at Chung Shan Medical University Hospital. The study aims to evaluate the clinical efficacy and safety of a novel sperm-wash device-LensHooke CA0-in couples with infertility undergoing intrauterine insemination (IUI). A total of 120 couples will be enrolled and randomly assigned in a 1:1 ratio to the intervention group (LensHooke CA0) or the control group (DGC).
Sperm quality will be evaluated before and after processing, and IUI will be performed following standard clinical procedures. The primary outcome is the clinical pregnancy rate confirmed by ultrasound. The secondary outcome is the sperm DNA fragmentation index (DFI), assessed using the Sperm Chromatin Dispersion (SCD) test.
The study hypothesizes that the novel sperm-wash device will improve pregnancy outcomes and reduce oxidative stress and DNA damage compared to the conventional method. The trial aims to provide supporting evidence for a more physiological and efficient sperm selection strategy in assisted reproduction.
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
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged between 25 to 50 years.
- •Part of a couple diagnosed with infertility.
- •Undergoing intrauterine insemination (IUI) treatment.
- •Sperm concentration >15 million/mL, progressive motility >32%, and total motile sperm count >40 million after wash.
- •Willingness of both partners to participate and provide informed consent.
排除标准
- •Known female infertility factors requiring assisted reproductive technologies beyond IUI.
- •Severe male factor infertility (e.g., oligoasthenoteratozoospermia).
- •Use of donor sperm or oocyte.
- •Chronic illness or medications affecting sperm quality.
- •Prior participation in another clinical trial within the past 3 months.
研究组 & 干预措施
Novel Sperm-Wash Device (CA0) Group
Participants in this arm will undergo sperm preparation using the LensHooke CA0 device. The device applies a filtration and swim-up mechanism to select sperm with improved motility, morphology, and DNA integrity, while reducing oxidative stress. The processed sperm will be used for intrauterine insemination (IUI). Outcomes including clinical pregnancy rate, reactive oxygen species (ROS) levels, and sperm DNA fragmentation index (DFI) will be assessed.
干预措施: LensHooke CA0 (Device)
Conventional DGC Group
Participants in this arm will undergo sperm preparation using the standard density gradient centrifugation (DGC) method. This widely used technique separates motile sperm based on density. The processed sperm will then be used for intrauterine insemination (IUI). The same outcome measures as in the experimental group will be evaluated.
干预措施: Density Gradient Centrifugation (DGC) (Procedure)
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: Within 6 weeks after IUI
Defined as the presence of an intrauterine gestational sac with fetal heartbeat confirmed by transvaginal ultrasound after intrauterine insemination (IUI). The outcome aims to evaluate the effectiveness of the novel sperm-wash device (LensHooke CA0) compared to conventional density gradient centrifugation (DGC) in improving clinical pregnancy outcomes following IUI.
次要结局
- Sperm DNA Fragmentation Index (DFI)(On the day of intrauterine insemination (IUI))
研究者
Tsung-Hsien Lee
Doctor of Medicine (M.D.), Doctor of Philosophy (Ph.D.)
Chung Shan Medical University