[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532257":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Wolfson Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gel group","EXPERIMENTAL","Speculum insertion using sterile water-based gel",[13],"Other: Sterile water-based gel",{"label":15,"type":16,"description":17,"interventionNames":18},"Sterile water group","NO_INTERVENTION","Speculum insertion using sterile water",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"OTHER","Sterile water-based gel","Insertion of the speculum during ET will be performed using 5 gr of water-based, sterile gel",[9],[26],{"name":27,"affiliation":28,"role":29},"Daniel Tairy, MD","Edith Wolfson Medical Center","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","+972-54-5315875","danieltairy1@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Yossi Mizrachi, MD","+972-54-5234053","mizrachi.yossi@gmail.com",[40],{"facility":41,"status":42,"city":43,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Faculty of Medical and Health Sciences","RECRUITING","Tel Aviv","Israel","IL",{"type":47,"coordinates":48},"Point",[49,50],34.78057,32.08088,{"lat":50,"lon":49},[53],{"name":36,"role":32,"phone":54,"phoneExt":18,"email":38},"972545234053",{"type":29,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Yossi Mizrachi","Principal Investigator","100532257","speculum-insertion-during-embryo-transfer-100532257",false,"NCT06210451","Speculum Insertion During Embryo Transfer","Lubricant Gel Versus Sterile Water for Speculum Insertion During Embryo Transfer: a Randomized Non-inferiority Clinical Trial","Inclusion Criteria:\n\n* Age 18-40\n* Fresh and thawed ET\n* Patients undergoing their 1st-3rd ET\n* ET of 1-2 embryos\n\nExclusion Criteria:\n\n* Age\\>40\n* Egg donation cycles",true,"FEMALE","18 Years","40 Years",{"count":70,"type":71},416,"ESTIMATED","INTERVENTIONAL",[74],"NA","Lubrication gels are widely used in numerous gynecologic procedures in order to ease the insertion of speculum and visualize the cervix. It was shown that applying lubricating gels significantly decreases patient pain during vaginal speculum examination. While many fertility specialists use lubrication gels to insert the speculum during embryo transfer (ET), others are strongly reluctant to use gels due to concern that they might have a detrimental effect on embryos and ET success. Similar concern was prevalent regarding the use of lubrication gel during Pap-smear for detection of cervical dysplasia. However, several studies have shown that the use of small amount of water-soluble gel does not change cervical cytology. Lubrication gels might have deleterious effect on sperm motility. However, there wasn't any study examining the effect of lubricant gel on ET success.\n\nThe investigators hypothesize that using a lubrication gel will not reduce the live birth rate per transfer, but decrease patient pain during procedure.",[77],"IVF",[77,79,80,81],"Embryo transfer","Gel","RCT","2024-07-22",{"date":84,"type":85},"2024-07-24","ACTUAL",{"date":87,"type":85},"2024-05-01",{"date":89,"type":71},"2026-12-31",{"name":5,"class":6},1]