[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649087":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":10,"eligibilityCriteria":42,"healthyVolunteers":39,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":10},{"fullName":5,"class":6},"Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)","OTHER",[8,13,17],{"label":9,"type":10,"description":10,"interventionNames":11},"B - Injectable GnRH Antagonist (Ganirelix\u002FCetrorelix)",null,[12],"Drug: Ganirelix ; Cetrorelix",{"label":14,"type":10,"description":10,"interventionNames":15},"C - PPOS (Progestin-Primed Ovarian Stimulation) Cohort",[16],"Drug: Medroxyprogesterone Acetate ; Dienogest ; Micronized Progesterone",{"label":18,"type":10,"description":10,"interventionNames":19},"A - Linzagolix",[20],"Drug: Linzagolix",[22,27,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DRUG","Ganirelix ; Cetrorelix","Ganirelix Type: Drug Group: B Description: Ganirelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation.\n\nCetrorelix Type: Drug Arm: B Description: Cetrorelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Medroxyprogesterone Acetate ; Dienogest ; Micronized Progesterone","Medroxyprogesterone Acetate Type: Drug Group: C Description: Medroxyprogesterone acetate 10 mg\u002Fday administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy.\n\nDienogest Type: Drug Arm: C Description: Dienogest 2 mg\u002Fday administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy.\n\nMicronized Progesterone Type: Drug Arm: C Description: Micronized progesterone 100-200 mg\u002Fday administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy.",[14],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Linzagolix","Description: Linzagolix Type: Drug Group: A Description: Linzagolix 200 mg administered orally once daily, started per center protocol (fixed stimulation day or upon appearance of the dominant follicle) and continued through the day of trigger. Investigational off-label use for suppression of the premature LH surge during controlled ovarian stimulation.",[18],{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100649087","oral-gnrh-antagonist-linzagolix-versus-injectable-gnrh-antagonist-and-progestin-primed-ovarian-stimulation-ppos-in-controlled-ovarian-stimulation-for-in-vitro-fertilization-a-prospective-comparative-observational-study-100649087",false,"NCT07732348","Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist and Progestin-primed Ovarian Stimulation (PPOS) in Controlled Ovarian Stimulation for in Vitro Fertilization: a Prospective Comparative Observational Study","Inclusion Criteria:\n\n* Female, aged 18 to 42 years\n* Indication for IVF\u002FICSI with controlled ovarian stimulation at CENTRO AMBRA\n* Population unselected for ovarian reserve (normal, poor, and high responders are eligible)\n* Written informed consent, including consent for off-label use of linzagolix and for data processing\n* For the two antagonist arms (Linzagolix and Injectable GnRH Antagonist): acceptance of randomization\n\nExclusion Criteria:\n\n* Known contraindications or hypersensitivity to the study drugs\n* Uterine pathology relevant to the study outcome (e.g., uterine malformations, significant submucosal fibroids)\n* Contraindications to pregnancy or to ovarian stimulation\n* Concurrent participation in another interfering interventional study","FEMALE","18 Years","42 Years",{"count":47,"type":48},195,"ESTIMATED","OBSERVATIONAL","Preventing a premature rise in luteinizing hormone (LH) is essential during ovarian stimulation for in vitro fertilization (IVF), because such a rise can reduce the number of eggs collected. Current practice relies on either a daily injectable GnRH antagonist or an oral progestin (PPOS), which requires that all embryos be frozen.\n\nLinzagolix is an oral GnRH antagonist already approved for uterine fibroids and endometriosis. It has not previously been used to control ovarian stimulation for IVF; this study represents its first use for this purpose.\n\nThis is an observational study: participants are not randomly assigned to a treatment. Each woman receives one of three approaches - oral linzagolix, an injectable GnRH antagonist (ganirelix or cetrorelix), or PPOS - chosen by the clinical team based on her individual situation. The three groups are then compared using statistical adjustment for baseline differences between them.\n\nThe study will enroll approximately 195 women undergoing IVF or ICSI, aged 18 to \\[42\\], who are not selected based on ovarian reserve. All participants receive individualized gonadotropin stimulation and standard monitoring; only the method used to prevent premature ovulation differs by group.\n\nThe main question is whether linzagolix leads to a similar number of mature eggs (MII) retrieved compared with the injectable antagonist. The study will also assess how well each approach suppresses LH, safety (including ovarian hyperstimulation), and the number of injections needed.",[52,53],"Infertility, Female","Ovulation Induction",[55,32,56,57,58,59,60,61],"Oral GnRH Antagonist","Controlled Ovarian Stimulation","In Vitro Fertilization","ICSI","Progestin-Primed Ovarian Stimulation","Oocyte Maturation","OHSS Prevention","NOT_YET_RECRUITING","2026-07-31",{"date":65,"type":66},"2026-08-03","ACTUAL",{"date":68,"type":48},"2026-09",{"date":70,"type":48},"2026-12",{"name":5,"class":6}]