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The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
Sponsor: Chung Shan Medical University
Summary
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.
Key Details
Gender
MALE
Age Range
25 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-04-24
Completion Date
2026-12-31
Last Updated
2025-05-08
Healthy Volunteers
No
Conditions
Interventions
LensHooke CA0
The intervention involves the use of the LensHooke CA0 sperm-wash device, which incorporates filtration and swim-up techniques to isolate motile and morphologically normal sperm with intact DNA integrity. It is used for sperm preparation in intrauterine insemination (IUI) cycles. The device is designed to reduce oxidative stress and facilitate physiological sperm selection, providing a potential improvement over conventional density gradient centrifugation (DGC).
Density Gradient Centrifugation (DGC)
The control procedure involves the standard density gradient centrifugation (DGC) method, a widely accepted technique for sperm preparation in IUI. Semen samples are processed using commercially available gradient media to isolate progressively motile sperm. This method serves as the comparator to assess the clinical performance of the LensHooke CA0 device.
Locations (1)
Chung Shan Medical University Hospital
Taichung, Taichung City, Taiwan