[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527169":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":63,"collaborators":31,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Density Gradient Centrifugation (DGC)","ACTIVE_COMPARATOR","During this procedure, raw semen sample is placed on 2 gradients: a lower phase (80%) and an upper phase (40%) followed by centrifugation. The composition of the gradients include a colloidal suspension of silica particles. At the end of centrifugation, each spermatozoa is situated at the gradient level that matches its density. The highly motile, morphologically normal, viable spermatozoa form a pellet at the bottom of the tube.",[13],"Other: Density Gradient Centrifugation",{"label":15,"type":16,"description":17,"interventionNames":18},"ZyMōt Multi (850µL)","EXPERIMENTAL","ZyMōt Multi (850µL) is a flow-free dual chambered single-use device. The first chamber contains a sample inlet and a fluid channel separated from the second collection chamber by an 8-μm microporous membrane. Channel dimension and membrane porosity are designed to optimize the sorting and collection of the most motile sperm. Sorting is accomplished by the passage of sperm through the micropores of the membrane. This procedure does not require any preliminary semen processing, all centrifugation steps being eliminated.",[19],"Device: ZyMōt Multi (850µL)",[21,27],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","An amount of 850 µl untreated semen sample will be loaded into the inlet chamber with a help of a sterile insulin-type syringe. A volume of 750 µl of Sage Quinn's AdvantageTM Medium with Hepes + 5% HSA-solution medium will be placed on top of the membrane (outlet chamber). After 30 min of incubation in a humidified incubator (37°C), 500 µl of medium, containing the selected spermatozoa, will be retrieved from the upper side of the membrane (retrieval chamber). An amount of 400 µl will be necessary for the IUI procedure.",[15],[26],"FERTILE Plus® device (KOEK EU GmbH, Biotechnology)",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Density Gradient Centrifugation","The gradient columns will be prepared by placing 1 ml 80% gradient media in a centrifuge tube and an additional 1 ml of 40% gradient layered on top.\n\nThe raw semen sample will be placed on top of the gradient (1ml semen\u002Fgradient tube) and centrifuged at 300xg for 20 minutes. The sperm pellet will be collected and washed 2 times for 5 min at 800xg in Sage Quinn's AdvantageTM Medium with Hepes + 5% HSA-solution.\n\nThe resulted pellet will be resuspended in the washing solution in a volume that will provide at least 1x106 forward motile spermatozoa in 400 µl, as this amount is necessary for IUI procedure.",[9],null,[33],{"name":34,"affiliation":5,"role":35},"Shari Mackens, MD, PhD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Elsie Nulens","CONTACT","0032 2 4742676","elsie.nulens@uzbrussel.be",{"name":43,"role":39,"phone":44,"phoneExt":31,"email":45},"Ileana Mateizel, PhD","0032 24749119","ileana.mateizel@uzbrussel.be",[47],{"facility":48,"status":49,"city":50,"state":31,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"UZ Brussel CRG","RECRUITING","Brussels","1090","Belgium","BE",{"type":55,"coordinates":56},"Point",[57,58],4.34878,50.85045,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":31,"phoneExt":31,"email":31},"Ileana G Mateizel, PhD",{"type":64,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100527169","live-birth-rate-after-sperm-selection-using-zymt-multi-850l-device-for-intra-uterine-insemination-100527169",false,"NCT06144268","Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination","Evaluation of Live Birth Rate After Sperm Selection Using Microfluidic Technology (ZyMōt Multi (850µL) Sperm Separation Device) for Intra Uterine Insemination.","FERTINSEM","Inclusion Criteria:\n\n* Fresh autologous ejaculate\n* Female age: \\\u003C37 at start of the first insemination\n* 1st IUI ever here, maximum 3 consecutive IUIs during max 6 months\n* BMI \\\u003C35\n* All natural cycles, ovulation induction allowed\n* Presence of 1 or 2 follicles at the last ultrasound\n* Regular menses (26-35 days)\n* \\>1 million Total Progressive Motile Sperm Count (TPMC) after previous routine capacitation with DGC\n* Presence of at least 1 potent tube after Hyfosy\n\nExclusion Criteria:\n\n* Presence of intracavitary pathology at ultrasound\n* Evidence of advance endometriosis (Grade 3 and 4)",true,"ALL","18 Years","36 Years",{"count":78,"type":79},240,"ESTIMATED","INTERVENTIONAL",[82],"NA","This single centre interventional pilot randomized control study intends to compare two methods of sperm preparation for couples referred for Intra Uterine Insemination (IUI) procedure. Couples will be randomly allocated to one of the two sperm selection methods: Density Gradient Centrifugation (DGC, standard) or ZyMōt Multi (850µL) device (treatment) groups. The study will compare the live birth rate (number of live births per number of IUI procedures) between the treatment and standard groups.",[85,86],"Infertility","Fertility Disorders",[88,89,90],"Intra Uterine Insemination","Live birth","Microfluidic sperm selection","2024-01-29",{"date":93,"type":94},"2024-01-30","ACTUAL",{"date":96,"type":94},"2024-01-10",{"date":98,"type":79},"2027-12",{"name":5,"class":6},1]