[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605235":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":38,"locations":46,"responsibleParty":66,"collaborators":25,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"EMBRIONARE","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Traditional Letrozole Therapy","ACTIVE_COMPARATOR","Participants in this group will receive standard letrozole therapy for ovulation induction. Letrozole will be administered orally at a dose of 5 mg\u002Fday from cycle day 2 through cycle day 6 (5 consecutive days). Ovulation monitoring will be performed by transvaginal ultrasound and confirmed with urinary LH testing and\u002For corpus luteum visualization. This arm serves as the active comparator against the extended regimen for evaluating efficacy and safety outcomes.",[13],"Drug: Traditional Letrozole Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Extended Letrozole Therapy","EXPERIMENTAL","Participants in this group will receive extended letrozole therapy for ovulation induction. Letrozole will be administered orally at a dose of 5 mg\u002Fday from cycle day 2 through cycle day 12 (10 consecutive days). Ovulation monitoring will be performed by transvaginal ultrasound and confirmed with urinary LH testing and\u002For corpus luteum visualization. This arm will be compared with the standard regimen to assess differences in ovulation rate, follicular development, pregnancy outcomes, and safety.",[19],"Drug: Extended Letrozole Therapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Traditional therapy group: 5 mg\u002Fday of letrozole for 5 days (cycle days 2-6).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Extended therapy group: 5 mg\u002Fday of letrozole for 10 days (cycle days 2-12)",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Gabriel M Pinheiro, MD","Universidade Santo Amaro","STUDY_DIRECTOR",{"name":35,"affiliation":36,"role":37},"Katherine Ann R Miller, Medical student","Universisty of Santo Amaro","PRINCIPAL_INVESTIGATOR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":25,"email":42},"CONTACT","+55(11) 964098358","katherinereimao000@gmail.com",{"name":31,"role":40,"phone":44,"phoneExt":25,"email":45},"+55(11) 97130-7240","Drg.monteiro@hotmail.com",[47],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Health Complex Dr Wladimir Arruda","RECRUITING","São Paulo","04829-310","Brazil","BR",{"type":55,"coordinates":56},"Point",[57,58],-46.63611,-23.5475,{"lat":58,"lon":57},[61,63],{"name":31,"role":40,"phone":62,"phoneExt":25,"email":45},"+55(11)97130-7240",{"name":64,"role":40,"phone":65,"phoneExt":25,"email":42},"Katherine Ann R Miller, Undergraduate medical student","+55 (11) 96409-8358",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","GABRIEL MONTEIRO PINHEIRO","Study Director, Obstetrician and Gynecologist, Department of Obstetrics and Gynecology, Hospital Wladimir Arruda; Professor of Obstetrics and Gynecology, University of Santo Amaro (UNISA)","100605235","letrozole-extended-vs-traditional-therapy-for-ovulation-induction-in-women-with-pcos-prolex-pcos-100605235",false,"NCT07159880","Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)","Extended Therapy Versus Traditional Therapy With Letrozole for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial","PROLEx-PCOS","Inclusion Criteria:\n\n* Women aged 18 to 40 years;\n* BMI between 18,5 and 31 kg\u002Fm2\n* Diagnosis of Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria (2003) (presence of at least two of the following: oligo\u002Fanovulation, clinical and\u002For biochemical hyperandrogenism, polycystic ovarian morphology on ultrasound);\n* Active desire for pregnancy at the time of enrollment;\n* Ability and willingness to provide written informed consent (ICF).\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>40 years;\n* Presence of confirmed bilateral tubal factor, severe male factor infertility, premature ovarian insufficiency, uncontrolled hyperprolactinemia or thyroid dysfunction);\n* Congenital or acquired uterine malformations;\n* History of gynecologic or breast cancer;\n* Known hypersensitivity to, or contraindication for, letrozole;\n* Severe uncontrolled systemic disease (e.g., cardiovascular, renal, or hepatic disorders);\n* Pregnancy or breastfeeding at the time of screening.",true,"FEMALE","18 Years","40 Years",{"count":83,"type":84},20,"ESTIMATED","INTERVENTIONAL",[87],"NA","This randomized clinical trial aims to compare the efficacy and safety of extended letrozole therapy (5 mg\u002Fday for 10 days) versus standard letrozole therapy (5 mg\u002Fday for 5 days) for ovulation induction in women with polycystic ovary syndrome (PCOS). A total of 84 women aged 18-40 years will be randomized into two groups. Ovulation will be monitored by transvaginal ultrasound and confirmed with urinary LH testing and\u002For corpus luteum presence. The primary outcome is ovulation rate, while secondary outcomes include number and size of mature follicles, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, number of cycles until pregnancy, and incidence of ovarian hyperstimulation syndrome (OHSS).",[90,91,92],"PCOS (Polycystic Ovary Syndrome)","Infertility","Anovulation",[94,95,96,97,98,99,100,101,102,103,104,105],"polycystic ovary syndrome","PCOS","Ovulation induction","Letrozole","Aromatase Inhibitor","Extended letrozole therapy","traditional letrozole therapy","standart letrozole therapy","infertility","anovulation","ovulation rate","pregnancy rate","2025-11-23",{"date":108,"type":109},"2025-11-28","ACTUAL",{"date":111,"type":109},"2025-09-01",{"date":113,"type":84},"2026-07-30",{"name":68,"class":6},1]