[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544686":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":48,"responsibleParty":81,"collaborators":42,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":42,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":42,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Mỹ Đức Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Letrozole-stimulated cycle strategy (LETS)","ACTIVE_COMPARATOR","to fourth day of the menstrual cycle.\n\nPost-letrozole, ultrasound checks follicle growth. If ≥18mm, Ovitrelle® 250 mcg (Merck, Kenilworth, New Jersey, USA) induces ovulation.\n\nLuteal phase support with vaginal micronized progesterone (Cyclogest® 400 milligrams, Actavis, UK or Utrogestan® 200 milligrams, Besins, Belgium) 800 milligrams\u002Fday starting two days post-hCG.\n\nEmbryo transfer, 5 days post-progesterone. Ultrasounds use Samsung HS-30, vaginal probe, and ≥7.5MHz frequency. Hormonal support until the 12th gestational week with vaginal micronized progesterone 800 milligrams\u002Fday.\n\nCycle cancellation criteria: no follicle development on day 21 from the day of starting letrozole, spontaneous ovulation, letrozole intolerance, fluid retention. Cycle cancellation will be noted as a study's outcome.",[13],"Procedure: Letrozole-stimulated cycle strategy",{"label":15,"type":10,"description":16,"interventionNames":17},"Artificial cycle strategy (AC)","Oral estradiol valerate (Progynova® 2 milligrams, Bayer Pharma AG, Germany or Valiera® 2 milligrams, Laboratories Recalcine, Chile) 6 milligrams\u002Fday for 10 days, starting on the second to fourth day of the menstrual cycle.\n\nPost-estradiol, ultrasound checks endometrial thickness. If ≥7mm, start vaginal micronized progesterone (Cyclogest® 400 milligrams, Actavis, UK or Utrogestan® 200 milligrams, Besins, Belgium) 800 milligrams\u002Fday. If \\\u003C7mm, increase the dose of oral estradiol valerate to 8 milligrams\u002Fday (5-6 days) and 12 milligrams\u002Fday (5-6 days).\n\nEmbryo transfer, 5 days post-progesterone. Ultrasounds use Samsung HS-30, vaginal probe, and ≥7.5MHz frequency. Hormonal support until the 12th gestational week with vaginal micronized progesterone 800 milligrams\u002Fday.\n\nCycle cancellation criteria: endometrial thickness \\\u003C7mm on day 21 of using estradiol, spontaneous ovulation, oral estradiol valerate intolerance, fluid retention. Cycle cancellation will be noted as a study's outcome.",[18],"Procedure: Artificial cycle strategy",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Letrozole-stimulated cycle strategy","Letrozole (Femara® 2.5 milligrams, Novartis, Switzerland or Lezra® 2.5 milligrams, Actavis, Rumani) 5 milligrams\u002Fday for 5 days, starting on the second to fourth day of the menstrual cycle.\n\nPost-letrozole, ultrasound checks follicle growth. If ≥18mm, Ovitrelle® 250 mcg (Merck, Kenilworth, New Jersey, USA) induces ovulation.\n\nLuteal phase support with vaginal micronized progesterone (Cyclogest® 400 milligrams, Actavis, UK or Utrogestan® 200 milligrams, Besins, Belgium) 800 milligrams\u002Fday starting two days post-hCG.\n\nEmbryo transfer, 5 days post-progesterone. Ultrasounds use Samsung HS-30, vaginal probe, and ≥7.5MHz frequency. Hormonal support until the 12th gestational week with vaginal micronized progesterone 800 milligrams\u002Fday.\n\nCycle cancellation criteria: no follicle development on day 21 from the day of starting letrozole, spontaneous ovulation, letrozole intolerance, fluid retention. Cycle cancellation will be noted as a study's outcome.",[9],[26],"LETS",{"type":21,"name":28,"description":16,"armGroupLabels":29,"otherNames":30},"Artificial cycle strategy",[15],[31],"AC",[33],{"name":34,"affiliation":35,"role":36},"Lan TN Vuong, Assoc. Prof.","University of Medicine and Pharmacy at Ho Chi Minh City","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Nam T Nguyen, MD.","CONTACT","+84354120209",null,"bsnam.nt@myduchospital.vn",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Vu NA Ho, MD.","+84935843336","bsvu.hna@myduchospital.vn",[49,67],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"My Duc Hospital","RECRUITING","Ho Chi Minh City","70000","Vietnam","VN",{"type":57,"coordinates":58},"Point",[59,60],106.62965,10.82302,{"lat":60,"lon":59},[63,65],{"name":64,"role":40,"phone":46,"phoneExt":42,"email":47},"Vu NA Ho, MD",{"name":66,"role":40,"phone":41,"phoneExt":42,"email":43},"Nam T Nguyen, MD",{"facility":68,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"My Duc Phu Nhuan Hospital",{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},[73,77],{"name":74,"role":40,"phone":75,"phoneExt":42,"email":76},"Ho L Le, MD","+84356177147","bsho.ll@myduchospital.vn",{"name":78,"role":40,"phone":79,"phoneExt":42,"email":80},"Tien K Le, MD","+84962803875","bstien.lk@myduchospital.vn",{"type":82,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100544686","letrozole-stimulated-cycle-strategy-versus-artificial-cycle-strategy-letsact-100544686",false,"NCT06372119","Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT)","Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy for Endometrial Preparation in Women With Irregular Menstrual Cycles: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged between 18 - 42.\n* Irregular menstrual cycle (\\\u003C 21 days or \\> 35 days or \\\u003C 8 cycles\u002Fyears).\n* Indicated for endometrial preparation.\n* Transfer of only one blastocyst.\n* Not participating in any other trials.\n\nExclusion Criteria:\n\n* Allergy to letrozole or Ovitrelle or oral estradiol valerate or micronized progesterone\n* Having embryos from either oocyte donation or PGT (pre-implantation genetics testings) cycles.\n* Ovarian cysts that are unrelated to the oocyte pick-up.\n* Confirmed diagnosis with recurrent pregnancy loss (RPL) according to ESHRE guideline 2023, recurrent implantation failure (RIF) according to ESHRE 2023 good practice recommendations.\n* Endometrial abnormalities include endometrial hyperplasia, intrauterine adhesions, endometrial polyp, and chronic endometritis.\n* Uterine abnormalities include leiomyomas L0, L1, or L2 (according to FIGO 2011); adenomyosis (according to MUSA 2022); congenital uterine abnormalities, include didelphus, arcuate, unicornuate, bicornuate, septate (according to ASRM 2021).\n* Untreated hydrosalpinx.",true,"FEMALE","18 Years","42 Years",{"count":95,"type":96},790,"ESTIMATED","INTERVENTIONAL",[99],"NA","The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation. The primary question it aims to answer is:\n\n• Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation?\n\nParticipants will undergo screening before endometrial preparation for frozen embryo transfer, following which they will be randomly assigned to one of two groups: LETS or AC. In the LETS group, investigators will prescribe letrozole 5 milligrams\u002Fday for 5 days to stimulate follicular development and micronized progesterone 800 milligrams\u002Fday for luteal phase support. In contrast, the AC group will receive oral estradiol valerate 6-12 milligrams\u002Fday and micronized progesterone 800 milligrams\u002Fday. Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates.",[102,103,104,105],"Embryo Transfer","Irregular Menstruation","Letrozole","Hormone Replacement Therapy",[107,103,104,105],"Blastocyst Transfer","2025-09-22",{"date":110,"type":111},"2025-09-25","ACTUAL",{"date":113,"type":111},"2024-04-22",{"date":115,"type":96},"2026-04",{"name":5,"class":6},2]