{"id":"fix-dose-r-fsh-gonal-f","safety":{"commonSideEffects":[{"rate":null,"effect":"Ovarian hyperstimulation syndrome (OHSS)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Abdominal pain/bloating"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"r-FSH is a recombinant version of the naturally occurring pituitary hormone FSH that binds to FSH receptors on granulosa cells of ovarian follicles, promoting their development and estrogen production. This controlled follicular stimulation is essential for assisted reproductive technologies to obtain multiple mature oocytes for fertilization. The fixed-dose formulation allows standardized dosing during ovarian stimulation cycles.","oneSentence":"Recombinant follicle-stimulating hormone (r-FSH) stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:46:30.335Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ovarian stimulation in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF)"},{"name":"Anovulation and oligo-ovulation in women seeking pregnancy"}]},"trialDetails":[{"nctId":"NCT07269327","phase":"PHASE1","title":"An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2025-11-24","conditions":"Fertility","enrollment":24},{"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":"NCT05266924","phase":"PHASE3","title":"Recombinant Follicle-stimulating Hormone in Treatment for Infertility","status":"UNKNOWN","sponsor":"Bharat Serums and Vaccines Limited","startDate":"2022-07-23","conditions":"Female Infertility","enrollment":250},{"nctId":"NCT04899193","phase":"PHASE1","title":"Pergoveris FD and Liquid China BE Study","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2021-05-08","conditions":"Healthy","enrollment":72},{"nctId":"NCT00249834","phase":"PHASE4","title":"Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2004-09-22","conditions":"Infertility","enrollment":166},{"nctId":"NCT00749853","phase":"PHASE3","title":"Efficacy of Ovarian Stimulation Based on FSHR Genotype Status","status":"SUSPENDED","sponsor":"Medical University of Vienna","startDate":"2015-05","conditions":"Sterility","enrollment":165},{"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":"NCT01210144","phase":"PHASE4","title":"EXpression PRofile Endometrium Samples Study","status":"TERMINATED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2008-08","conditions":"In Vitro Fertilization","enrollment":27},{"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["puregon"],"phase":"marketed","status":"active","brandName":"fix dose r-FSH (Gonal-f)","genericName":"fix dose r-FSH (Gonal-f)","companyName":"Sisli Hamidiye Etfal Training and Research Hospital","companyId":"sisli-hamidiye-etfal-training-and-research-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Recombinant follicle-stimulating hormone (r-FSH) stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment. Used for Ovarian stimulation in women undergoing assisted reproductive technology (ART) including in vitro fertilization (IVF), Anovulation and oligo-ovulation in women seeking pregnancy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}