[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516499":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":79,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"microfluidic chip method","EXPERIMENTAL","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).\n\nIn the microfluidic chip method for sperm sorting, a small amount of semen sample is loaded onto the chip, which contains channels and chambers that allow for the separation of sperm based on their motility and morphology. The chip is designed to mimic the natural environment of the female reproductive tract, where sperm undergo a series of selection processes before reaching the egg.",[13],"Device: Microfluidic chip",{"label":15,"type":16,"description":17,"interventionNames":18},"density-gradient centrifugation method","ACTIVE_COMPARATOR","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.",[19],"Device: Density-gradient centrifugation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Microfluidic chip","The Sperm Separation Device - ZyMōt Multi 850µL (ZyMōt Fertility, Inc) will be used. The microfluidics chamber will be used according to the manufacturer's instructions. 850 μL of the semen sample will be inserted into the inlet port of the device and 750 μL of fertilization media will be inserted into the outlet port. The device with the semen sample inside will be incubated in 6% CO2 at 37°C. After 30 min, 500 μL of the sample at the outlet port will be removed from the outlet port and pipetted into a labelled test tube.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Density-gradient centrifugation","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.",[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","100516499","microfluidic-chip-method-versus-density-gradient-centrifugation-method-in-ivf-100516499",false,"NCT06005311","Microfluidic Chip Method Versus Density-gradient Centrifugation Method in IVF","A Randomized Double-blind Controlled Study of the Cumulative Live Birth Rate of IVF Following Sperm Preparation by Microfluidic Chip Method Versus Density-gradient Centrifugation Method","Inclusion Criteria:\n\n* Infertile women aged \\\u003C43 years at the time of ovarian stimulation for IVF\n\nExclusion Criteria:\n\n* Women undergoing preimplantation genetic testing monogenic diseases, structural rearrangement of chromosomes or aneuploidy;\n* Male factor requiring surgical sperm retrieval such as microscopic epididymal sperm aspiration and testicular sperm extraction;\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},1136,"ESTIMATED","INTERVENTIONAL",[75],"NA","Infertile patients attending IVF treatment 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: (1) the microfluidic chip group and (2) the density gradient group for sperm preparation and subsequent use in fertilization. Other IVF procedures will be the same as our usual practice. Both patients and clinicians were blinded from the group allocation i.e. a double blind study. The primary outcome is the cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation.",[78],"Infertility",[80,81,82,83],"microfluidic chip","density-gradient centrifugation","in-vitro fertilisation","sperm preparation","2024-12-03",{"date":86,"type":87},"2024-12-06","ACTUAL",{"date":89,"type":87},"2024-11-01",{"date":91,"type":72},"2029-11-30",{"name":59,"class":6},1]