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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age25-50
SponsorChung Shan Medical University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • LensHooke CA0
  • Density Gradient Centrifugation (DGC)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators