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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
LensHooke CA0
DeviceThe 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).
Density Gradient Centrifugation (DGC)
Procedure/SurgeryThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Novel Sperm-Wash Device (CA0) GroupExperimental treatment 1 intervention
Group B: Conventional DGC GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Pregnancy Rate
Defined as the presence of an intrauterine gestational sac with fetal heartbeat confirmed by transvaginal ultrasound after intrauterine insemination (IUI). The outcome aims to evaluate the effectiveness of the novel sperm-wash device (LensHooke CA0) compared to conventional density gradient centrifugation (DGC) in improving clinical pregnancy outcomes following IUI.
Time frame
Within 6 weeks after IUISecondary outcomes
1
Sperm DNA Fragmentation Index (DFI)
The percentage of sperm with fragmented DNA assessed using the Sperm Chromatin Dispersion (SCD) test. This outcome evaluates DNA integrity of sperm processed by the CA0 device compared to conventional density gradient centrifugation (DGC).
Time frame
On the day of intrauterine insemination (IUI)Sponsors and contacts
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Source ClinicalTrials.gov