The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
Recruiting now · Not applicable
Conditions studied: Infertility, Male Infertility
In brief
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 facts
- Study ID
- NCT06956287
- Run by
- Chung Shan Medical University
- People needed
- 120
- Starts
- 2025-04-24
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-05-08
Who can join
Age: 25 and older, up to 50. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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.
Where it is running
- Chung Shan Medical University Hospital — Taichung, Taichung City, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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