The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 25
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Chung Shan Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
Tsung-Hsien Lee, M.D., Ph.D.
jackth.lee@gmail.com
+886920823519
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Chung Shan Medical University

This content was sourced from clinicaltrials.gov