[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589582":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":40,"locations":46,"responsibleParty":64,"collaborators":44,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":44,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":49,"whyStopped":44,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Chung Shan Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Novel Sperm-Wash Device (CA0) Group","EXPERIMENTAL","Participants in this arm will undergo sperm preparation using the LensHooke CA0 device. The device applies a filtration and swim-up mechanism to select sperm with improved motility, morphology, and DNA integrity, while reducing oxidative stress. The processed sperm will be used for intrauterine insemination (IUI). Outcomes including clinical pregnancy rate, reactive oxygen species (ROS) levels, and sperm DNA fragmentation index (DFI) will be assessed.",[13],"Device: LensHooke CA0",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional DGC Group","ACTIVE_COMPARATOR","Participants in this arm will undergo sperm preparation using the standard density gradient centrifugation (DGC) method. This widely used technique separates motile sperm based on density. The processed sperm will then be used for intrauterine insemination (IUI). The same outcome measures as in the experimental group will be evaluated.",[19],"Procedure: Density Gradient Centrifugation (DGC)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","LensHooke CA0","The 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).",[9],[27],"CA0",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Density Gradient Centrifugation (DGC)","The 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.",[15],[34,35],"Conventional sperm preparation","gradient centrifugation",[37],{"name":38,"affiliation":5,"role":39},"Tsung-Hsien Lee, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","+886920823519",null,"jackth.lee@gmail.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Chung Shan Medical University Hospital","RECRUITING","Taichung","Taichung City","40201","Taiwan","TW",{"type":56,"coordinates":57},"Point",[58,59],120.6839,24.1469,{"lat":59,"lon":58},[62],{"name":63,"role":42,"phone":43,"phoneExt":44,"email":45},"Tsung-Hsien Lee, M.D., Ph.D",{"type":39,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Tsung-Hsien Lee","Doctor of Medicine (M.D.), Doctor of Philosophy (Ph.D.)","100589582","the-efficiency-of-a-new-sperm-wash-device-for-intrauterine-insemination-in-couples-with-infertility-100589582",false,"NCT06956287","The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility","IUI","Inclusion Criteria:\n\n* Males aged between 25 to 50 years.\n* Part of a couple diagnosed with infertility.\n* Undergoing intrauterine insemination (IUI) treatment.\n* Sperm concentration \\>15 million\u002FmL, progressive motility \\>32%, and total motile sperm count \\>40 million after wash.\n* Willingness of both partners to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Known female infertility factors requiring assisted reproductive technologies beyond IUI.\n* Severe male factor infertility (e.g., oligoasthenoteratozoospermia).\n* Use of donor sperm or oocyte.\n* Chronic illness or medications affecting sperm quality.\n* Prior participation in another clinical trial within the past 3 months.","MALE","25 Years","50 Years",{"count":78,"type":79},120,"ESTIMATED","INTERVENTIONAL",[82],"NA","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.\n\nIn 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.",[85,86],"Infertility","Male Infertility",[85,88,89,90,91,92,93,94],"intrauterine insemination (IUI)","artificial insemination husband","sperm selection","sperm DNA fragmentation","oxidative stress","fertility treatment","male infertility","2025-05-05",{"date":97,"type":98},"2025-05-08","ACTUAL",{"date":100,"type":98},"2025-04-24",{"date":102,"type":79},"2026-12-31",{"name":5,"class":6},1]