[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Trust Fertility Clinic\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100619876","phase-4-trial-comparing-subcutaneous-natural-progesterone-prolutex-vs-cetrorelix-acetate-for-luteinizing-hormone-surge-suppression-in-freeze-all-ivf-cycles-100619876",false,"NCT07350317","Trial Comparing Subcutaneous Natural Progesterone (Prolutex) vs. Cetrorelix Acetate for Luteinizing Hormone Surge Suppression in Freeze-All IVF Cycles.","A Non-Inferiority Randomized Controlled Trial Comparing Subcutaneous Natural Progesterone (Prolutex) vs. Cetrorelix Acetate for Luteinizing Hormone Surge Suppression in Freeze-All IVF Cycles.","IVF ART","Inclusion Criteria:\n\n1. Women aged 18-40 years.\n2. Body Mass Index \\\u003C 35 kg\u002Fm²\n3. Antral Follicle Count ≥ 8 or Anti-Müllerian Hormone ≥ 1.2 ng\u002FmL\n4. Undergoing freeze-all IVF (for Ovarian Hyperstimulation Syndrome - OHSS risk, PGT- Preimplantation Genetic Testing, or personal preference)\n\nExclusion Criteria:\n\n1. Poor responders (Bologna criteria)\n2. Stage III-IV endometriosis\n3. Pituitary or hypothalamic dysfunction\n4. Planned fresh embryo transfer\n5. Severe Male Factor. Semen Count \\\u003C1 ×〖10〗\\^6 (\\\u003C1 Million\u002Fml) or Azoospermia)","FEMALE","18 Years","40 Years",{"count":21,"type":22},230,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The prevention of premature luteinizing hormone (LH) surge during controlled ovarian stimulation (COS) is critical for optimizing outcomes in assisted reproductive technology (ART). Cetrorelix acetate, a GnRH (Gonadotropin releasing hormone) antagonist administered subcutaneously, is the current standard for luteinizing hormone suppression. However, natural progesterone in a novel subcutaneous formulation (Prolutex) may offer a viable alternative.\n\nProlutex is a water-soluble complex of natural progesterone with hydroxypropyl-β-cyclodextrin (HPBCD), patented as US Patent No. 4,727,064 Pitha, Jallowing for subcutaneous injection. This may simplify treatment and improve patient compliance.\n\nProgesterone forms are well studied and used globally\u002Fin UAE to suppress Luteinizing Hormone surge. It is an example of off-label use, which becomes a standard indication for use of progesterone. Several studies have demonstrated that exogenous progesterone can effectively suppress Luteinizing Hormone release while maintaining follicular development and oocyte competence. Furthermore, progestin-based protocols are potentially more cost-effective and similar to administer compared to GnRH (Gonadotropin releasing hormone) antagonists.\n\nTo our knowledge, this is the first randomized trial directly comparing a subcutaneous progesterone formulation (Prolutex) with cetrorelix acetate, administered via the same route, in terms of luteinizing hormone surge suppression. For this specific research, there are no relevant published studies available. This Randomised controlled trial will be done to address the research gap and compare the two already approved standard of care medications to see if Prolutex can be used as a viable alternative to suppress Luteinizing Hormone levels.",[28],"Assisted Reproductive Techniques",[30,31,32],"ivf protocol","prolutex","premature ovulation","NOT_YET_RECRUITING","2026-01-13",{"date":36,"type":37},"2026-01-20","ACTUAL",{"date":39,"type":22},"2026-01",{"date":41,"type":22},"2027-02",{"name":43,"class":44},"Trust Fertility Clinic","OTHER",""]