NCT06956287 The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
| NCT ID | NCT06956287 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chung Shan Medical University |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-04-24 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-04-24 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Tsung-Hsien Lee, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Chung Shan Medical University
Frequently Asked Questions
Who can join the NCT06956287 clinical trial?
This trial is open to male participants only, aged 25 Years or older, up to 50 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06956287 currently recruiting?
Yes, NCT06956287 is actively recruiting participants. Contact the research team at jackth.lee@gmail.com for enrollment information.
Where is the NCT06956287 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT06956287 clinical trial?
NCT06956287 is sponsored by Chung Shan Medical University. The principal investigator is Tsung-Hsien Lee, M.D., Ph.D. at Chung Shan Medical University. The trial plans to enroll 120 participants.