[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559421":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":26,"locations":18,"responsibleParty":36,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":18,"maxAge":18,"enrollmentInfo":51,"targetDuration":18,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":64,"whyStopped":18,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":18},{"fullName":5,"class":6},"Mỹ Đức Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lipiodol® uterine treatment prior to IVF\u002FICSI","EXPERIMENTAL","For those who are randomized to Lipiodol®, treatment will be performed by a HSG technique with X-ray screening on day 3 or day 5 after oocyte retrieval. The contrast medium will be Lipiodol Ultra Fluide® (Guerbet, France), an iodized poppy seed oil obtained by substitution of ethyl esters for the glyceryl esters of Lipiodol®. After that the procedure to assess study participants' pain perception.\n\nEndometrial preparation for frozen embryo transfer will perform on the subsequence cycle",[13],"Procedure: Lipiodol® uterine treatment prior to IVF\u002FICSI",{"label":15,"type":16,"description":17,"interventionNames":18},"No Lipiodol® uterine treatment prior to IVF\u002FICSI","NO_INTERVENTION","For those who are randomized to no intervention arm (control group), there will be no HSG performed.\n\nEndometrial preparation for frozen embryo transfer will perform on the subsequence cycle",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Lipiodol®, treatment will be performed by a HSG technique with X-ray screening on day 3 or day 5 after oocyte retrieval. The contrast medium will be Lipiodol Ultra Fluide® (Guerbet, France), an iodized poppy seed oil obtained by substitution of ethyl esters for the glyceryl esters of Lipiodol®. One millilitre of Lipiodol Ultra Fluide® contains 0.48g iodine. Women will lie in the left lateral or supine position. Radiologists will use a 'no touch' technique after applying antiseptic solution to the cervix. Uterine cannulation using the Cook HSG catheter will be applied to conduct Lipiodol® treatment. Prewarmed (37oC) Lipiodol® will be slowly instilled, with intermittent fluoroscopic X-ray guidance. Up to 10 ml of Lipiodol® will be slowly injected into the uterus and directly monitored by fluoroscopy. If intravasation was observed on X-ray (contrast apparent in the venous system), instillation will be stopped immediately.",[9],[25],"Lipiodol® flushing prior to IVF\u002FICSI",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":18,"email":31},"Tuong M Ho, MD","CONTACT","(+84) 903633377","tuongho.ivfmd@gmail.com",{"name":33,"role":29,"phone":34,"phoneExt":18,"email":35},"Tien K Le, MD","(+84) 962803875","bstien.lk@myduchospita.vn",{"type":37,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[39],{"name":40,"class":41},"Guerbet","INDUSTRY","100559421","lipiodol-prior-to-fet-life-100559421",false,"NCT06563908","Lipiodol Prior to FET (LIFE)","Lipiodol® For Enhancing Live Birth Rates In Infertile Couples Undergoing In Vitro Fertilization\u002F Intracytoplasmic Sperm Injection A Randomized Controlled Trial","LIFE","Inclusion Criteria:\n\n* Women undergoing IVF\u002FICSI\n* Having indications for freeze-all (day-3 or day-5)\n* Agree to have ≤ 2 frozen embryos transferred\n* TSH \\\u003C 2.5 mIU\u002FmL\n* Permanent resident in Viet Nam\n* Agree to participate in the study by signing the inform consent\n\nExclusion Criteria:\n\n* Iodine allergy\n* History of salpingectomy or tubal ligation\n* History of using Lipiodol® within 6 months prior, starting from the screening time\n* At high risk of having Fallopian tube disorders (history of Chlamydia infection, history of pelvic inflammatory diseases, current endometriosis)\n* Having evidence of Fallopian tube disorders on Hysterosalpingo - Foam Sonography (HyFoSy), hysterosalpingography (HSG), ultrasonography or laparoscopy\n* Having untreated intrauterine lesions such as endometrial polyps, submucosal fibroids, etc which affect the outcome of IVF treatment\n* Have a history of thyroid disease or being treated for thyroid disease\n* Undergoing curettage within 30 days before performing HSG technique\n* Patients having embryos from oocyte donation or in vitro maturation (IVM) cycles\n* Unable or unwilling to attend Lipiodol® procedure\n* Participating in another interventional study at the same time","FEMALE",{"count":52,"type":53},784,"ESTIMATED","INTERVENTIONAL",[56],"NA","Lipiodol® flushing is an effective fertility treatment for women with unexplained infertility. It is speculated that the treatment effect could work through a direct effect of Lipiodol® on the endometrium. Given this direct effect on the endometrium, it is further hypothesized that Lipiodol® uterine treatment prior to In Vitro Fertilization (IVF)\u002F Intracytoplasmic Sperm Injection (ICSI) may also improve pregnancy rates. However, the effectiveness of Lipiodol® as an adjunct to IVF\u002FICSI treatment has not previously been examined in a well-powered and properly conducted randomised clinical trial.",[59,60,61],"IVF","Frozen Embryo Transfer","Hysterosalpingography",[63,61],"Lipiodol","NOT_YET_RECRUITING","2024-08-18",{"date":67,"type":68},"2024-08-21","ACTUAL",{"date":70,"type":53},"2024-08-10",{"date":72,"type":53},"2026-12",{"name":5,"class":6}]