{"id":"recombinant-lh-luveris","safety":{"commonSideEffects":[{"rate":null,"effect":"Ovarian hyperstimulation syndrome (OHSS)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Abdominal pain/discomfort"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Luveris is a recombinant form of human luteinizing hormone that binds to LH receptors on ovarian theca cells, stimulating androgen production which is converted to estrogen by granulosa cells. It is used in combination with follicle-stimulating hormone (FSH) to support controlled ovarian hyperstimulation in assisted reproductive technology. This hormone replacement approach is particularly valuable in women with hypogonadotropic hypogonadism or those requiring exogenous LH supplementation during fertility treatment.","oneSentence":"Recombinant luteinizing hormone (LH) stimulates the ovaries to produce estrogen and progesterone, promoting follicle development and ovulation in women with LH deficiency.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:04:19.826Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Infertility in women with LH and FSH deficiency undergoing assisted reproductive technology"},{"name":"Anovulation or oligo-ovulation in women with hypogonadotropic hypogonadism"}]},"trialDetails":[{"nctId":"NCT07340827","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)","status":"RECRUITING","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2026-02-05","conditions":"Infertility","enrollment":333},{"nctId":"NCT07128394","phase":"NA","title":"Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment","status":"RECRUITING","sponsor":"Nanjing University","startDate":"2024-02-01","conditions":"Infertility, Female, Luteinizing Hormone (LH)","enrollment":590},{"nctId":"NCT06883890","phase":"PHASE2","title":"Extended LH Administration","status":"NOT_YET_RECRUITING","sponsor":"Azienda Ospedaliero-Universitaria di Modena","startDate":"2025-03-17","conditions":"Ovarian Reserve","enrollment":84},{"nctId":"NCT03741699","phase":"PHASE3","title":"Recombinant LH Prior to Ovarian Stimulation in Poor Ovarian Responders (PRE-LH)","status":"COMPLETED","sponsor":"Instituto Valenciano de Infertilidad, IVI Alicante","startDate":"2019-02-18","conditions":"Infertility, Female","enrollment":88},{"nctId":"NCT06571214","phase":"PHASE4","title":"Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment","status":"NOT_YET_RECRUITING","sponsor":"Nanjing University","startDate":"2024-09-01","conditions":"Infertility","enrollment":300},{"nctId":"NCT05405686","phase":"PHASE4","title":"Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders","status":"WITHDRAWN","sponsor":"CRG UZ Brussel","startDate":"2023-05-01","conditions":"Poor Response to Ovulation Induction","enrollment":""},{"nctId":"NCT04189133","phase":"PHASE2","title":"Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men","status":"UNKNOWN","sponsor":"Azienda Ospedaliero-Universitaria di Modena","startDate":"2022-01-19","conditions":"Acquired Hypogonadotropic Hypogonadism","enrollment":32},{"nctId":"NCT02200952","phase":"","title":"Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS","status":"COMPLETED","sponsor":"San Carlo Public Hospital, Potenza, Italy","startDate":"2013-06-30","conditions":"Ovarian Hyperstimulation Syndrome","enrollment":16},{"nctId":"NCT00889512","phase":"PHASE4","title":"The Luveris In Vitro Fertilization Trial","status":"TERMINATED","sponsor":"University Reproductive Associates","startDate":"2009-04","conditions":"Infertility, Hypothalamic Amenorrhea, Hyperprolactinemia","enrollment":14},{"nctId":"NCT01457703","phase":"NA","title":"Reproductive Hormonal Alterations in Obesity","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2010-06","conditions":"Obesity","enrollment":62},{"nctId":"NCT02820415","phase":"","title":"PGS on Blastocysts From Vitrified and Fresh Oocytes","status":"COMPLETED","sponsor":"Unità di Medicina della Riproduzione, Italy","startDate":"2014-06","conditions":"Increase the Number of Blastocyst to Biopsy for Preimplantation Genetic Testing","enrollment":60},{"nctId":"NCT01204840","phase":"PHASE2","title":"Growth Hormone for Poor Responders in in Vitro Fertilization (IVF)","status":"COMPLETED","sponsor":"Ottawa Fertility Centre","startDate":"2010-09","conditions":"Infertility, Poor Ovarian Reserve","enrollment":38},{"nctId":"NCT02108223","phase":"PHASE4","title":"The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI","status":"COMPLETED","sponsor":"Sisli Hamidiye Etfal Training and Research Hospital","startDate":"2009-01","conditions":"Infertility","enrollment":137},{"nctId":"NCT01604044","phase":"PHASE1","title":"Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.","status":"COMPLETED","sponsor":"Catholic University of the Sacred Heart","startDate":"2012-05","conditions":"Female Infertility","enrollment":579},{"nctId":"NCT01936077","phase":"PHASE4","title":"Severe LH Suppressed Patients After Administration of a GnRH Antagonist","status":"COMPLETED","sponsor":"Assuta Hospital Systems","startDate":"2010-06","conditions":"Infertility, Female Infertility, Male Infertility","enrollment":50},{"nctId":"NCT00328926","phase":"PHASE4","title":"Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])","status":"TERMINATED","sponsor":"EMD Serono","startDate":"2006-03","conditions":"Hypogonadotropic Hypogonadism","enrollment":11},{"nctId":"NCT00820482","phase":"PHASE4","title":"Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination.","status":"COMPLETED","sponsor":"Instituto Valenciano de Infertilidad, IVI VALENCIA","startDate":"2009-01","conditions":"Ovarian Stimulation Preceding Intrauterine Insemination","enrollment":80},{"nctId":"NCT00553293","phase":"PHASE4","title":"Nordic Luveris Study","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2003-08","conditions":"Infertility, In Vitro Fertilization","enrollment":526},{"nctId":"NCT00441324","phase":"PHASE4","title":"Efficacy and Safety of R-hLH (Luveris ®) Priming Prior to R-HFSH Treatment in Infertile Women Undergoing IVF-ET","status":"COMPLETED","sponsor":"NHS Greater Glasgow and Clyde","startDate":"2003-03","conditions":"Infertility","enrollment":160}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Luveris"],"phase":"marketed","status":"active","brandName":"Recombinant LH (Luveris)","genericName":"Recombinant LH (Luveris)","companyName":"Azienda Ospedaliero-Universitaria di Modena","companyId":"azienda-ospedaliero-universitaria-di-modena","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Recombinant luteinizing hormone (LH) stimulates the ovaries to produce estrogen and progesterone, promoting follicle development and ovulation in women with LH deficiency. Used for Infertility in women with LH and FSH deficiency undergoing assisted reproductive technology, Anovulation or oligo-ovulation in women with hypogonadotropic hypogonadism.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}