The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
Chung Shan Medical University
120 participants
Apr 24, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria5
- 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.
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Interventions
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).
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)
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NCT06956287