[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632051":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":51,"interventions":62,"overallOfficials":70,"centralContacts":75,"locations":80,"responsibleParty":142,"collaborators":41,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":41,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":116,"whyStopped":41,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"University of Aarhus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Pregnancy Rate","Defined as an ultrasonographically visible foetal heartbeat at 7-9 weeks of gestation","Gestational age 7-9 weeks",[14,18,22,26,30,34,37],{"measure":15,"description":16,"timeFrame":17},"Live Birth Rate","Defined as the birth of one or more living infants after a pregnancy of GA ≥ 22 weeks","At the time of delivery",{"measure":19,"description":20,"timeFrame":21},"Biochemical Pregnancy Rate","Defined as a positive serum or urine β-hCG test 14-17 days after intrauterine insemination","14-17 days after intrauterine insemination",{"measure":23,"description":24,"timeFrame":25},"Early Pregnancy Loss","Defined as intrauterine pregnancy loss before 10 weeks of gestational age","Up to 10 weeks of gestation",{"measure":27,"description":28,"timeFrame":29},"Fetal miscarriage","Defined as pregnancy loss ≥ 10 weeks size with a fetus (≥ 33 mm) on ultrasound","From 10 weeks of gestation to delivery",{"measure":31,"description":32,"timeFrame":33},"Obstetric outcomes","Obstetric complications including hypertensive disorders of pregnancy, gestational diabetes, postpartum hemorrhage and cesarean section","At time of delivery",{"measure":35,"description":36,"timeFrame":33},"Perinatal outcomes","Preterm birth, birth weight, congenital malformations, and perinatal mortality (defined as foetal or neonatal death from GA 22+0 to 7 days after birth).",{"measure":38,"description":39,"timeFrame":40},"Hormone levels","Serum hormone levels measured on the day of insemination, in the mid-luteal phase and on the day of ovulation trigger (optional), including progesterone, estradiol, LH and FSH.","Time of insemination and mid-luteal phase (approximately 7-9 days after insemination).",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":48,"whoMasked":49},"SINGLE","Outcome assessment is performed by a physician masked to treatment allocation. Participants and treating clinical staff are not masked.",[50],"OUTCOMES_ASSESSOR",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Intervention","EXPERIMENTAL","Vaginal progesterone luteal phase support. Progesterone is administered as Cyclogest 400 mg twice daily form the day after insemination. Treatment is continued until gestational age 10 weeks in the event of clinical pregnancy, or until pregnancy is ruled out in women who do not achieve a clinical pregnancy.",[57],"Drug: Progesterone",{"label":59,"type":60,"description":61,"interventionNames":41},"Comparison","NO_INTERVENTION","No luteal phase support will be administered after insemination, reflecting current standard treatment.",[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"DRUG","Progesterone","Vaginal progesterone (Cyclogest) 400 mg administered twice daily starting the day after insemination. Treatment is continued until gestational age 10 weeks in the event of clinical pregnancy or until clinical pregnancy is ruled out.",[53],[69],"Cyclogest",[71],{"name":72,"affiliation":73,"role":74},"Kirstine Kirkegaard, Clinical Associate Professor","University Clinic for Fertility, Horsens Regional Hospital, Central Denmark Region","PRINCIPAL_INVESTIGATOR",[76],{"name":72,"role":77,"phone":78,"phoneExt":41,"email":79},"CONTACT","+4578426562","fertilitet@horsens.rm.dk",[81,100,115,127],{"facility":82,"status":83,"city":84,"state":41,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Copenhagen University Hospital - Rigshospitalet. Department of Gynecology, Fertility and Obstetrics","NOT_YET_RECRUITING","Copenhagen","2100","Denmark","DK",{"type":89,"coordinates":90},"Point",[91,92],12.56553,55.67594,{"lat":92,"lon":91},[95,99],{"name":96,"role":77,"phone":97,"phoneExt":41,"email":98},"Kristine Løssl, Clinical Associate Professor","+4535451077","fertilitet.rigshospitalet@regionh.dk",{"name":96,"role":74,"phone":41,"phoneExt":41,"email":41},{"facility":101,"status":83,"city":102,"state":41,"zip":103,"country":86,"countryCode":87,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"The Fertility Clinic, Herlev Hospital","Herlev","2730",{"type":89,"coordinates":105},[106,107],12.43998,55.72366,{"lat":107,"lon":106},[110,114],{"name":111,"role":77,"phone":112,"phoneExt":41,"email":113},"Maria Birkvad Rasmussen, Clinical Associate Professor","+4538683868","HEH-gynaekologisk-obstetrisk.afdeling.g@regionh.dk",{"name":111,"role":74,"phone":41,"phoneExt":41,"email":41},{"facility":73,"status":116,"city":117,"state":41,"zip":118,"country":86,"countryCode":87,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"RECRUITING","Horsens","8700",{"type":89,"coordinates":120},[121,122],9.85034,55.86066,{"lat":122,"lon":121},[125,126],{"name":72,"role":77,"phone":78,"phoneExt":41,"email":79},{"name":72,"role":74,"phone":41,"phoneExt":41,"email":41},{"facility":128,"status":83,"city":129,"state":41,"zip":130,"country":86,"countryCode":87,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"The Fertility Clinic, Hvidovre Hospital","Hvidovre","2650",{"type":89,"coordinates":132},[133,134],12.47708,55.64297,{"lat":134,"lon":133},[137,141],{"name":138,"role":77,"phone":139,"phoneExt":41,"email":140},"Nina la Cour Freiesleben, Clinical Associate Professor","+4538622744","fertilitetsklinikken.amager-og-hvidovre-hospital@regionh.dk",{"name":138,"role":74,"phone":41,"phoneExt":41,"email":41},{"type":143,"investigatorFullName":144,"investigatorTitle":145,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Kirstine Kirkegaard","Clinical Associate Professor, MD, PhD","100632051","phase-4-progesterone-supplementation-after-letrozole-stimulated-insemination-100632051",false,"NCT07508657","Progesterone Supplementation After Letrozole-stimulated Insemination","Luteal Phase Support Following Letrozole Treatment in Women Undergoing Intrauterine Insemination: a Multicenter Randomized Trial","LIFT","Inclusion Criteria:\n\n* Age 18-37 years\n* Scheduled for IUI with homologous or donor sperm\n* Undergoing mild ovarian stimulation with letrozole\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\> 37 years\n* Anovulation due to hypogonadotropic hypogonadism\n* Known hypersensitivity to progesterone or hard fat listed as an excipient in the Summary of Product Characteristics (SmPC) for Cyclogest.\n* Known or suspected progesterone-sensitive malignant tumours\n* Porphyria\n* Known missed abortion or ectopic pregnancy\n* Active arterial or venous thromboembolism, severe thrombophlebitis, or a history of these conditions\n* Severe hepatic dysfunction or liver disease\n* Inability to speak or understand Danish sufficiently to comprehend oral and written study information","FEMALE","18 Years","37 Years",{"count":158,"type":159},690,"ESTIMATED","INTERVENTIONAL",[162],"PHASE4","This trial aims to investigate whether luteal phase support improves the chance of pregnancy in women undergoing intrauterine insemination (IUI) following ovarian stimulation with letrozole.\n\nIn this randomized clinical trial, 690 women undergoing letrozole-stimulated IUI at four public fertility clinics in Denmark will be randomly allocated to one of two groups:\n\n* Vaginal progesterone from the day after insemination (Cyclogest 400 mg twice daily)\n* No luteal phase support, reflecting current clinical practice\n\nAll participants will undergo a standard letrozole-stimulated IUI treatment, including ultrasound monitoring, ovulation triggering, and insemination. Blood samples will be collected on the day of insemination and 7-9 days after insemination to measure hormone levels.\n\nThe results of this trial will provide further insight into the role of progesterone support in letrozole-stimulated IUI cycles.",[165],"Infertility",[167,168,169,170,171,172],"Luteal phase support","Intrauterine insemination","Letrozole","Vaginal progesterone","Randomized clinical trial","Ovulation induction","2026-09-02",{"date":175,"type":176},"2026-09-09","ACTUAL",{"date":178,"type":176},"2026-08-28",{"date":180,"type":159},"2030-01",{"name":144,"class":6},4]