[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517894":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":26,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The microfluidic chip group","EXPERIMENTAL","The Sperm Separation Device - ZyMōt Multi 850µL or 3 mL device (ZyMōt Fertility, Inc) will be used according to the volume of the raw semen samples. The microfluidics chamber will be used based on the manufacturer's instructions. 850 μL (850 μL device) or 3 mL (3mL device) of the semen sample will be added to the inlet port of the device and 750 μL (850 μL device) or 2.4 mL (3 mL device) of fertilization media will be added to the outlet port. The device will then be incubated in 6% CO2 at 37°C. After 30 minutes, 500 μL (850 μL device) or 1 mL (3mL device) of the prepared sample at the outlet port will be removed and pipetted into a labelled test tube.",[13],"Device: microfluidic chip",{"label":15,"type":16,"description":17,"interventionNames":18},"The density gradient centrifugation group","ACTIVE_COMPARATOR","After liquefaction, sperm preparation will be completed by a discontinuous density gradient centrifugation method, using Pureception (CooperSurgical, Denmark) sperm density gradient media. The resulting sperm pellet after centrifugation will be washed once with the sperm washing medium (G-IVF Plus, Vitrolife, Sweden) The washed spermatozoa will be resuspended with the same medium, adjusting the final volume to 0.5 mL.",[19],"Device: density gradient centrifugation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","microfluidic chip","Microfluidic chip method has been used for sperm sorting in order to select the most motile and morphologically normal sperm for use in assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"density gradient centrifugation","Density-gradient centrifugation is a commonly used method for sperm separation and purification. It is a technique that involves layering a semen sample on top of a gradient of different densities of a solution, typically a mixture of colloidal silica and sucrose, and then centrifuging the sample. The centrifugal force causes the sperm to migrate through the gradient, where they become separated based on their density.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"YU WING TONG, MBBS","CONTACT","92707722","ptong@connect.hku.hk",[38],{"facility":39,"status":40,"city":41,"state":41,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of Obstetrics and Gynaecology","RECRUITING","Hong Kong","China","CN",{"type":45,"coordinates":46},"Point",[47,48],114.17469,22.27832,{"lat":48,"lon":47},[51,55],{"name":52,"role":34,"phone":53,"phoneExt":26,"email":54},"Ernest HY NG, MD","852-22553400","nghye@hku.hk",{"name":52,"role":56,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Professor Ernest Hung-Yu Ng","Clinical Professor","100517894","microfluidic-chip-vs-density-gradient-centrifugation-on-the-euploidy-rate-of-pre-implantation-genetic-testing-100517894",false,"NCT06023472","Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing","A Randomized Comparison of Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing","Inclusion Criteria:\n\n* Women aged \\\u003C43 years at the time of ovarian stimulation for IVF\n* Women undergoing PGT for monogenic diseases, structural rearrangement of chromosomes or aneuploidy\n* Sperm concentration of the raw semen with at least 0.15 million motile sperm per ml or 100 motile sperm per 50 low power field (200x) of observation\n\nExclusion Criteria:\n\n* Use of frozen semen for insemination\n* Use of donor oocytes and spermatozoa\n* Submucosal fibroid or hydrosalpinx shown on pelvic scanning and not surgically treated;\n* Women who had been recruited into this study before and\n* Women joining other randomized trials","ALL","43 Years",{"count":71,"type":72},318,"ESTIMATED","INTERVENTIONAL",[75],"NA","Infertile women attending for PGT at the Centre of Assisted Reproduction and Embryology, Queen Mary Hospital and Kwong Wah Hospital will be recruited during ovarian stimulation for IVF. Subsequently, they will be randomly assigned on the day of oocyte retrieval by a laboratory staff into one of the following two groups in a 1:1 ratio : (1) the microfluidic chip group and (2) the density gradient centrifugation group for sperm preparation and subsequent use in fertilization. Other IVF procedures will be the same as the standard practice of the Centre. Both women and clinicians will be blinded from the group allocation i.e. a double blind study.",[78,79,80,81],"Infertility","Genetic Disease","Chromosomal Rearrangement","Aneuploidy",[23,28,83,84],"euploidy rate","pre-implantation genetic testing","2024-12-03",{"date":87,"type":88},"2024-12-06","ACTUAL",{"date":90,"type":88},"2024-11-01",{"date":92,"type":72},"2028-11-30",{"name":59,"class":6},1]