{"id":"highly-purified-urinary-fsh","safety":{"commonSideEffects":[{"rate":null,"effect":"Ovarian hyperstimulation syndrome (OHSS)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Abdominal pain or bloating"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL2107879","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FSH is a gonadotropin that binds to FSH receptors on granulosa cells in ovarian follicles (in women) and Sertoli cells in seminiferous tubules (in men). In women, it promotes follicular growth and maturation, leading to increased estrogen production and ovulation. In men, it stimulates spermatogenesis and testicular function. This urinary-derived formulation is a naturally sourced alternative to recombinant FSH.","oneSentence":"Highly purified urinary FSH (follicle-stimulating hormone) stimulates follicular development and estrogen production in women, and spermatogenesis in men.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:22:31.196Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Female infertility due to anovulation or low ovarian reserve"},{"name":"Male infertility due to hypogonadotropic hypogonadism or low sperm production"},{"name":"Assisted reproductive technology (ART) / in vitro fertilization (IVF)"}]},"trialDetails":[{"nctId":"NCT03373149","phase":"PHASE2","title":"Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response","status":"UNKNOWN","sponsor":"Riyadh Fertility and Reproductive Health center","startDate":"2017-11-29","conditions":"Infertility, Female","enrollment":228},{"nctId":"NCT04268927","phase":"PHASE2","title":"Extended Letrozole Regimen Co-treatment With Gonadotropin Releasing Hormone Antagonist Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Poor Responders Undergoing IVF-ET","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2018-04-01","conditions":"Infertility","enrollment":106},{"nctId":"NCT02625519","phase":"PHASE4","title":"Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial)","status":"UNKNOWN","sponsor":"Instituto Bernabeu","startDate":"2015-12","conditions":"Reproductive Techniques, Assisted","enrollment":180},{"nctId":"NCT00335725","phase":"PHASE3","title":"Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.","status":"COMPLETED","sponsor":"IBSA Institut Biochimique SA","startDate":"2003-03","conditions":"Infertility","enrollment":151},{"nctId":"NCT02237755","phase":"PHASE2, PHASE3","title":"Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response.","status":"UNKNOWN","sponsor":"University of Athens","startDate":"2014-10","conditions":"Female Infertility","enrollment":50},{"nctId":"NCT02237781","phase":"PHASE2, PHASE3","title":"Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins","status":"UNKNOWN","sponsor":"University of Athens","startDate":"2014-10","conditions":"Female Infertility","enrollment":50},{"nctId":"NCT02099916","phase":"PHASE2, PHASE3","title":"Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF","status":"UNKNOWN","sponsor":"University of Athens","startDate":"2014-10","conditions":"Efficacy of DHEA, Pregnancy Rate, Diminished Ovarian Reserve","enrollment":50},{"nctId":"NCT00502281","phase":"PHASE4","title":"Controlled Ovarian Stimulation Followed by Timed Intercourse or Intrauterine Insemination in Infertile PCOS Patients","status":"SUSPENDED","sponsor":"University Magna Graecia","startDate":"2007-01","conditions":"Polycystic Ovary Syndrome","enrollment":100},{"nctId":"NCT00502229","phase":"PHASE4","title":"Therapy for Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin","status":"WITHDRAWN","sponsor":"University Magna Graecia","startDate":"2010-01","conditions":"Polycystic Ovary Syndrome, Infertility","enrollment":""},{"nctId":"NCT01219153","phase":"PHASE2","title":"Extended High Dose Letrozole Regimen Versus Short Low Dose Letrozole Regimen as an Adjuvant to GnRH Antagonist Protocol in the Management of Poor Responders Undergoing IVF-ET","status":"COMPLETED","sponsor":"Cairo University","startDate":"2008-09","conditions":"Infertility","enrollment":136}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":41,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"highly purified urinary FSH","genericName":"highly purified urinary FSH","companyName":"University Magna Graecia","companyId":"university-magna-graecia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Highly purified urinary FSH (follicle-stimulating hormone) stimulates follicular development and estrogen production in women, and spermatogenesis in men. Used for Female infertility due to anovulation or low ovarian reserve, Male infertility due to hypogonadotropic hypogonadism or low sperm production, Assisted reproductive technology (ART) / in vitro fertilization (IVF).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}