[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513770":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":65,"centralContacts":69,"locations":77,"responsibleParty":115,"collaborators":30,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":30,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":30,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":79,"whyStopped":30,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"ART Fertility Clinics LLC","OTHER",[8,18],{"label":9,"type":6,"description":10,"interventionNames":11},"Study Group","Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Blood for P4 measurement will be drawn upon admission to the clinic for the ET procedure. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure.",[12,13,14,15,16,17],"Diagnostic Test: Transvaginal ultrasound","Diagnostic Test: Serial serum LH, E2, P4","Diagnostic Test: Serum P4 day of ET - Study Group","Procedure: Embryo transfer","Diagnostic Test: Serum hCG 10 days after ET","Diagnostic Test: Serum P4 10 days after ET",{"label":19,"type":6,"description":20,"interventionNames":21},"Control Group","Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Administer on FET day 200 mg of P4 and increase to 300 mg\u002Fday from the day after the ET onwards until the pregnancy test. Blood for P4 measurement will be drawn before starting LPS in form of vaginal progesterone. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy.",[12,13,22,23,15,16,17],"Drug: Progesterone 100 Mg Vaginal Insert","Diagnostic Test: Serum P4 day of ET - Control Group",[25,31,35,42,46,50,57,61],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIAGNOSTIC_TEST","Transvaginal ultrasound","Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth",[19,9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Serial serum LH, E2, P4","Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng\u002Fml (Irani et al., 2017).",[19,9],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Progesterone 100 Mg Vaginal Insert","On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg\u002Fday from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy",[19],[41],"Progesterone 100Mg Vag Tab",{"type":26,"name":43,"description":44,"armGroupLabels":45,"otherNames":30},"Serum P4 day of ET - Control Group","Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure",[19],{"type":26,"name":47,"description":48,"armGroupLabels":49,"otherNames":30},"Serum P4 day of ET - Study Group","Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.",[9],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"PROCEDURE","Embryo transfer","The procedure in which embryo is placed in the uterus.",[19,9],[56],"ET",{"type":26,"name":58,"description":59,"armGroupLabels":60,"otherNames":30},"Serum hCG 10 days after ET","Pregnancy will be confirmed \u002F excluded by measurement of serum hCG 10 days after ET procedure and a level of \\> 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)",[19,9],{"type":26,"name":62,"description":63,"armGroupLabels":64,"otherNames":30},"Serum P4 10 days after ET","Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure",[19,9],[66],{"name":67,"affiliation":5,"role":68},"Barbara Lawrenz, PhD","PRINCIPAL_INVESTIGATOR",[70,74],{"name":67,"role":71,"phone":72,"phoneExt":30,"email":73},"CONTACT","+971 800 337845489","barbara.lawrenz@artfertilityclinics.com",{"name":75,"role":71,"phone":72,"phoneExt":30,"email":76},"Jonalyn Edades, RN","jonalyn.edades@artfertilityclinics.com",[78,92,103],{"facility":5,"status":79,"city":80,"state":30,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Abu Dhabi","60202","United Arab Emirates","AE",{"type":85,"coordinates":86},"Point",[87,88],54.39696,24.45118,{"lat":88,"lon":87},[91],{"name":67,"role":71,"phone":72,"phoneExt":30,"email":73},{"facility":93,"status":79,"city":94,"state":30,"zip":30,"country":82,"countryCode":83,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"ART Fertility Clinics Al Ain","Al Ain City",{"type":85,"coordinates":96},[97,98],55.76056,24.19167,{"lat":98,"lon":97},[101],{"name":102,"role":71,"phone":72,"phoneExt":30,"email":76},"Anastasia Salame",{"facility":104,"status":105,"city":106,"state":30,"zip":30,"country":82,"countryCode":83,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"ART Fertility Clinics Dubai","NOT_YET_RECRUITING","Dubai",{"type":85,"coordinates":108},[109,110],55.30927,25.07725,{"lat":110,"lon":109},[113],{"name":114,"role":71,"phone":72,"phoneExt":30,"email":76},"Carol Coughlan, PhD",{"type":68,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Barbara Lawrenz","Scientific Director","100513770","phase-1-comparison-of-live-birth-rate-in-natural-cycle-single-euploid-fet-versus-without-luteal-phase-support-100513770",false,"NCT05969795","Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support","Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)","Inclusion Criteria:\n\n* Age: 18 to 40 years\n* Regular ovulatory cycles\n* Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6\n* Detection of ovulation by P4 rise \\> 1.0 ng\u002Fml after LH surge\n* P4 value of at least 5 ng\u002Fml on day 4 after ovulation\n\nExclusion Criteria:\n\n* History of repeated pre-menstrual spotting\n* Factors affecting the implantation through anatomical changes of the uterus \u002F ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids \u002F polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)",true,"FEMALE","18 Years","40 Years",{"count":130,"type":131},342,"ESTIMATED","INTERVENTIONAL",[134],"PHASE1","To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.",[137,138],"Pregnancy Related","Infertility, Female",[140,141,142,143,144,145,146],"implantation rate","infertility","pregnancy rate","natural cycle","luteal phase support","live birth","progesterone","2025-01-08",{"date":149,"type":150},"2025-01-09","ACTUAL",{"date":152,"type":150},"2023-09-05",{"date":154,"type":131},"2026-09-30",{"name":5,"class":6},3]