Actively Recruiting
The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
Led by Chung Shan Medical University · Updated on 2025-05-08
120
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chung Shan Medical University Hospital
Taichung, Taichung City, Taiwan, 40201
Actively Recruiting
Research Team
T
Tsung-Hsien Lee, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here