{"id":"placebo-recfsh-follitropin-alfa","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,"_fixedAt":"2026-03-30T12:40:06.048097","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Follitropin alfa mimics endogenous FSH by binding to FSH receptors on granulosa cells of ovarian follicles, promoting follicle growth, maturation, and increased estrogen secretion. This is used in assisted reproductive technology to induce controlled ovarian hyperstimulation, enabling retrieval of multiple oocytes for in vitro fertilization or other fertility treatments.","oneSentence":"Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:28:31.133Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Infertility in women undergoing assisted reproductive technology (ART)"},{"name":"Anovulation and ovulatory dysfunction in women"}]},"_fixedFields":["modality→Biologic"],"trialDetails":[{"nctId":"NCT06091436","phase":"PHASE3","title":"To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference","status":"COMPLETED","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","startDate":"2023-03-24","conditions":"Infertility","enrollment":176},{"nctId":"NCT00703014","phase":"","title":"Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-07-13","conditions":"Pregnancy, Neonates","enrollment":541},{"nctId":"NCT00702273","phase":"","title":"Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-04-19","conditions":"In Vitro Fertilization","enrollment":344},{"nctId":"NCT00702195","phase":"","title":"Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-01-01","conditions":"Pregnancy","enrollment":29},{"nctId":"NCT00696800","phase":"PHASE3","title":"A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-06-27","conditions":"In Vitro Fertilization","enrollment":1509},{"nctId":"NCT01146418","phase":"PHASE3","title":"Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2010-06-02","conditions":"Infertility","enrollment":307},{"nctId":"NCT00702845","phase":"PHASE3","title":"To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-12-28","conditions":"Infertility","enrollment":397},{"nctId":"NCT00702624","phase":"","title":"Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2007-04","conditions":"Pregnancy, Neonates","enrollment":113},{"nctId":"NCT00702546","phase":"","title":"Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-12","conditions":"In Vitro Fertilization","enrollment":102},{"nctId":"NCT01144416","phase":"PHASE3","title":"Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2010-06","conditions":"Infertility","enrollment":1424}],"_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":[],"phase":"phase_3","status":"active","brandName":"Placebo RecFSH / follitropin alfa","genericName":"Placebo RecFSH / follitropin alfa","companyName":"Changchun GeneScience Pharmaceutical Co., Ltd.","companyId":"changchun-genescience-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Follitropin alfa is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and estrogen production in women. Used for Infertility in women undergoing assisted reproductive technology (ART), Anovulation and ovulatory dysfunction in women.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}