Evaluating a new sperm-wash device for improving intrauterine insemination outcomes in infertile couples
Official title: The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility
Run by Chung Shan Medical University · NCT06956287 · Data updated 2026-11-12
This study is testing a new sperm-wash device to see if it can help infertile couples have a better chance of getting pregnant through intrauterine insemination.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 25 Years to 50 Years |
| Sex | Men only |
| Enrollment | 120 (estimated) |
| Sponsor | Chung Shan Medical University Academic / other |
| Locations | 1 site (Taichung, Taichung City) |
| Status | Recruiting |
| Started | April 24, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 8, 2025 |
| Trial ID | NCT06956287 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include males aged 25 to 50 years who are part of a couple diagnosed with infertility and are undergoing IUI treatment.
✕Probably not a fit
Patients with known female infertility factors requiring more advanced reproductive technologies or severe male factor infertility may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial assesses the effectiveness of a novel sperm-wash device, LensHooke CA0, designed to enhance outcomes in intrauterine insemination (IUI) for couples facing infertility. The study involves 120 couples who will be randomly assigned to either the intervention group using the new device or a control group using traditional density gradient centrifugation (DGC). The primary outcome measured will be the clinical pregnancy rate, while secondary outcomes will include sperm DNA fragmentation. The hypothesis is that the new device will lead to higher pregnancy rates and lower DNA fragmentation compared to conventional methods.
Why it matters
Potential benefit: If successful, this study could lead to improved pregnancy rates for couples undergoing IUI by utilizing a more effective sperm selection method.
How similar studies have gone: While traditional sperm preparation methods have been widely used, this novel approach is relatively untested, making it a potentially innovative advancement in the field.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Chung Shan Medical University Hospital
Taichung, Taichung City, Taiwan Recruiting
Study contacts
- Principal investigator: Tsung-Hsien Lee, M.D., Ph.D. — Chung Shan Medical University
- Study coordinator: Tsung-Hsien Lee, M.D., Ph.D.
- Email: jackth.lee@gmail.com
- Phone: +886920823519
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.