{"id":"recombinant-fsh-rfsh","safety":{"commonSideEffects":[{"rate":null,"effect":"Ovarian hyperstimulation syndrome (OHSS)"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Abdominal pain/bloating"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"rFSH is a recombinant version of the naturally occurring pituitary hormone FSH that binds to FSH receptors on granulosa cells of ovarian follicles, promoting follicular development and estrogen production. This hormone replacement is used in assisted reproductive technology to induce controlled ovarian hyperstimulation, enabling the retrieval of multiple mature oocytes for in vitro fertilization or other fertility procedures.","oneSentence":"Recombinant FSH (follicle-stimulating hormone) stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:37:01.685Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Infertility in women undergoing assisted reproductive technology (ART)"},{"name":"Anovulation and ovulatory dysfunction in women seeking pregnancy"}]},"trialDetails":[{"nctId":"NCT07348757","phase":"","title":"rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study","status":"RECRUITING","sponsor":"Centrum Clinic IVF Center","startDate":"2026-01-05","conditions":"InVitro Fertilization, Gonadotropins","enrollment":300},{"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":"NCT06732843","phase":"","title":"Does Recombinant FSH (rFSH, i.g. Gonal F®) as Compared to Human Menopausal Gonadotrophin (hMG) Affect Telomere Length of Cumulus Cells During Antral Follicle Growth and Impact Blastocyst Status?","status":"RECRUITING","sponsor":"ART Fertility Clinics LLC","startDate":"2025-07-23","conditions":"OVARIAN STIMULATION, Telomere Length, Telomere Length, Mean Leukocyte","enrollment":10},{"nctId":"NCT06966219","phase":"","title":"Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection","status":"ACTIVE_NOT_RECRUITING","sponsor":"Suez University","startDate":"2025-05-01","conditions":"Infertility","enrollment":90},{"nctId":"NCT06921395","phase":"PHASE4","title":"Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).","status":"RECRUITING","sponsor":"LG Chem","startDate":"2025-02-15","conditions":"Female Infertility","enrollment":248},{"nctId":"NCT06321107","phase":"","title":"Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference","status":"ACTIVE_NOT_RECRUITING","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","startDate":"2024-03-01","conditions":"Infertility","enrollment":158},{"nctId":"NCT04773353","phase":"PHASE3","title":"Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2021-12-03","conditions":"Infertility","enrollment":220},{"nctId":"NCT02478775","phase":"NA","title":"Dysregulation of FSH in Obesity: Functional and Statistical Analysis","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2015-07","conditions":"Obesity, Fertility","enrollment":99},{"nctId":"NCT03846544","phase":"PHASE4","title":"Double Pick up in Poor Prognosis Women","status":"COMPLETED","sponsor":"CRG UZ Brussel","startDate":"2019-10-01","conditions":"Fertility Disorders","enrollment":48},{"nctId":"NCT06199960","phase":"PHASE3","title":"Dual Ovarian Stimulation (Duostim) and Shanghai Protocols in Poor Ovarian Responders","status":"COMPLETED","sponsor":"Royan Institute","startDate":"2019-08-02","conditions":"Assisted Reproductive Techniques","enrollment":116},{"nctId":"NCT05567731","phase":"NA","title":"Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve","status":"COMPLETED","sponsor":"Tanta University","startDate":"2022-10-15","conditions":"Intracytoplasmic Sperm Injection, GnRH Agonist, Infertility","enrollment":30},{"nctId":"NCT03296527","phase":"PHASE3","title":"Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2017-12-01","conditions":"Controlled Ovarian Simulation","enrollment":1011},{"nctId":"NCT04992468","phase":"PHASE4","title":"Dual Trigger for Elective Fertility Preservation","status":"COMPLETED","sponsor":"Fundación Santiago Dexeus Font","startDate":"2021-10-05","conditions":"Infertility","enrollment":136},{"nctId":"NCT01267604","phase":"PHASE4","title":"Ovarian Stimulation: Inositol and Melatonin","status":"WITHDRAWN","sponsor":"AGUNCO Obstetrics and Gynecology Centre","startDate":"2010-12","conditions":"Infertility","enrollment":""},{"nctId":"NCT05864937","phase":"","title":"C677T Methylenetetrahydrofolate Reductase Mutation","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2011-12-01","conditions":"Mutation","enrollment":363},{"nctId":"NCT04446845","phase":"PHASE4","title":"Double Stimulation Followed by a Fresh Embryo Transfer","status":"COMPLETED","sponsor":"Fundación Santiago Dexeus Font","startDate":"2020-10-30","conditions":"Infertility","enrollment":120},{"nctId":"NCT05370794","phase":"","title":"Is in Vitro Maturation of Oocytes Influenced by the Origin of Gonadotropins Used in Maturation Medium: is There a Difference in Efficiency When Using Urinary Versus Recombinant Produced Follicle Stimulating Hormone and Human Chorionic Gonadotropin","status":"UNKNOWN","sponsor":"Universitair Ziekenhuis Brussel","startDate":"2022-04-19","conditions":"In Vitro Maturation of Oocytes","enrollment":35},{"nctId":"NCT03423537","phase":"PHASE3","title":"Low-dose HCG as an Adjunct to Ovarian Stimulation in Subfertile Women Undergoing ART","status":"TERMINATED","sponsor":"National and Kapodistrian University of Athens","startDate":"2018-06-01","conditions":"HCG; IVF; Pregnancy Rates; ART; Chorionic Gonadotropin","enrollment":80},{"nctId":"NCT04325295","phase":"NA","title":"LOD vs Gn in Anovulatory PCOs Resistant to First Line Agents","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2020-12","conditions":"Polycystic Ovary Syndrome, Anovulation","enrollment":200},{"nctId":"NCT02418533","phase":"NA","title":"Mono-menotropins Versus rFSH Protocol on Embryo Quality","status":"COMPLETED","sponsor":"Main Line Fertility Center","startDate":"2015-03","conditions":"Infertility, Fertility","enrollment":109},{"nctId":"NCT02738580","phase":"PHASE4","title":"Follicular Steroid Genesis in Controlled Ovarian Stimulation","status":"COMPLETED","sponsor":"Instituto Valenciano de Infertilidad, IVI VALENCIA","startDate":"2016-10-18","conditions":"Infertility, Controlled Ovarian Hyperstimulation","enrollment":112},{"nctId":"NCT03463772","phase":"NA","title":"IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS","status":"UNKNOWN","sponsor":"Jie Qiao","startDate":"2018-03-16","conditions":"PCOS","enrollment":350},{"nctId":"NCT04122729","phase":"","title":"N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS","status":"UNKNOWN","sponsor":"Angelini Farmacéutica","startDate":"2019-09-25","conditions":"In Vitro Fertilization, Controlled Ovarian Stimulation","enrollment":300},{"nctId":"NCT03447184","phase":"","title":"Long-term Endogenous Androgen Priming in Bologna Criteria Poor Responder Patients - A Pilot Study","status":"COMPLETED","sponsor":"Mỹ Đức Hospital","startDate":"2018-03-26","conditions":"Poor Ovarian Response","enrollment":30},{"nctId":"NCT03921710","phase":"NA","title":"CAPA-IVM Versus STANDARD IVM","status":"COMPLETED","sponsor":"Mỹ Đức Hospital","startDate":"2017-04-29","conditions":"Infertility, Female","enrollment":80},{"nctId":"NCT00823472","phase":"PHASE4","title":"Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)","status":"TERMINATED","sponsor":"UMC Utrecht","startDate":"2009-01","conditions":"in Vitro Fertilization, Ovulation Induction","enrollment":147},{"nctId":"NCT03809221","phase":"PHASE4","title":"The Effectiveness and Safety of the Prolonged Down-regulation Protocol for Controlled Ovarian Hyperstimulation","status":"UNKNOWN","sponsor":"Peking University People's Hospital","startDate":"2019-02-01","conditions":"Infertility, Female","enrollment":1892},{"nctId":"NCT02606500","phase":"PHASE4","title":"Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success","status":"COMPLETED","sponsor":"University Medical Centre Ljubljana","startDate":"2016-03","conditions":"Obesity","enrollment":70},{"nctId":"NCT03118830","phase":"PHASE4","title":"Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI","status":"COMPLETED","sponsor":"Cairo University","startDate":"2017-04-21","conditions":"Invitro Fertilization","enrollment":204},{"nctId":"NCT03204253","phase":"NA","title":"Effects of Recombinant LH in Patients With Repeated Implantation Failure","status":"COMPLETED","sponsor":"University of Roma La Sapienza","startDate":"2016-01","conditions":"Female Infertility, Female Subfertility","enrollment":60},{"nctId":"NCT01961336","phase":"PHASE3","title":"Transdermal Testosterone Pretreatment in Poor Responders Undergoing IVF","status":"COMPLETED","sponsor":"Aristotle University Of Thessaloniki","startDate":"2013-10","conditions":"Subfertility","enrollment":50},{"nctId":"NCT02254928","phase":"PHASE4","title":"Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders","status":"TERMINATED","sponsor":"Vida Recoletas Sevilla","startDate":"2014-09","conditions":"Infertility","enrollment":26},{"nctId":"NCT02412904","phase":"PHASE4","title":"Randomized Controlled Trial Comparing Embryonic Quality in rFSH Versus hMG in IVF Protocol With GnRH Antagonist","status":"COMPLETED","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2014-01","conditions":"Infertility","enrollment":188},{"nctId":"NCT02442895","phase":"","title":"Biomarkers of Ovarian Reserve and Correlation With IVF Treatments","status":"COMPLETED","sponsor":"U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti","startDate":"2014-02","conditions":"Pregnancy, Ovarian","enrollment":236},{"nctId":"NCT02437032","phase":"PHASE4","title":"Gonadotropin Type in Ovarian Stimulation","status":"COMPLETED","sponsor":"IVI Madrid","startDate":"2009-04","conditions":"Infertility","enrollment":100},{"nctId":"NCT02140515","phase":"PHASE4","title":"Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation in Patients With Hypogonadotropic Hypogonadism","status":"UNKNOWN","sponsor":"Royan Institute","startDate":"2012-11","conditions":"Infertility","enrollment":90},{"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":"NCT02322398","phase":"","title":"Ovarian Stimulation With Recombinant Gonadotropins vs. Human Menopausal Gonadotropin in In Vitro Fertilization","status":"COMPLETED","sponsor":"University of Turin, Italy","startDate":"2010-03","conditions":"Infertility","enrollment":848},{"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":"NCT01225835","phase":"PHASE4","title":"Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2010-10","conditions":"Infertility","enrollment":124},{"nctId":"NCT01075815","phase":"PHASE2","title":"A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age","status":"TERMINATED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2008-11","conditions":"Infertility, Ovulation Induction","enrollment":76},{"nctId":"NCT01783301","phase":"PHASE4","title":"Anti-Mullerian Hormone (AMH) Versus Antral Follicle Count (AFC) Guided rFSH Dosing Study","status":"COMPLETED","sponsor":"Vietnam National University","startDate":"2011-10","conditions":"Infertility","enrollment":348},{"nctId":"NCT01760278","phase":"PHASE4","title":"Assessment of Implantation Potential of Embryos by Time-lapse Technology","status":"UNKNOWN","sponsor":"Bloom IVF and Fertility Centre","startDate":"2012-12","conditions":"Embryo/Fetus Death, Blastocyst Disintegration, Aneuploidy","enrollment":200},{"nctId":"NCT01365936","phase":"PHASE4","title":"hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF","status":"COMPLETED","sponsor":"Zekai Tahir Burak Women's Health Research and Education Hospital","startDate":"2008-01","conditions":"Polycystic Ovary Syndrome","enrollment":80},{"nctId":"NCT01509833","phase":"PHASE3","title":"Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection","status":"COMPLETED","sponsor":"Royan Institute","startDate":"2009-10","conditions":"Infertility","enrollment":73},{"nctId":"NCT00844311","phase":"PHASE4","title":"Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2009-02","conditions":"Infertility","enrollment":60},{"nctId":"NCT00257556","phase":"PHASE4","title":"A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2005-10","conditions":"Infertility","enrollment":80},{"nctId":"NCT00823121","phase":"PHASE1, PHASE2","title":"Replacement of Fresh Embryo Transfers (ETs) by Frozen Embryo Transfers (FETs) Using Vitrification","status":"UNKNOWN","sponsor":"Yazd Research & Clinical Center for Infertility","startDate":"2008-08","conditions":"In Vitro Fertilization","enrollment":500},{"nctId":"NCT01037699","phase":"PHASE3","title":"Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles","status":"COMPLETED","sponsor":"Instituto Valenciano de Infertilidad, IVI VALENCIA","startDate":"2005-01","conditions":"Ovarian Stimulation","enrollment":720},{"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":"NCT00830492","phase":"PHASE4","title":"Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist","status":"COMPLETED","sponsor":"Yazd Research & Clinical Center for Infertility","startDate":"2008-01","conditions":"Ovarian Stimulation","enrollment":200},{"nctId":"NCT00669786","phase":"PHASE3","title":"Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles","status":"COMPLETED","sponsor":"Instituto Valenciano de Infertilidad, IVI VALENCIA","startDate":"","conditions":"Ovarian Stimulation","enrollment":""},{"nctId":"NCT00553293","phase":"PHASE4","title":"Nordic Luveris Study","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2003-08","conditions":"Infertility, In Vitro Fertilization","enrollment":526}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":499,"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":"Recombinant FSH (rFSH)","genericName":"Recombinant FSH (rFSH)","companyName":"AGUNCO Obstetrics and Gynecology Centre","companyId":"agunco-obstetrics-and-gynecology-centre","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Recombinant FSH (follicle-stimulating hormone) stimulates the growth and maturation of ovarian follicles in women undergoing fertility treatment. Used for Infertility in women undergoing assisted reproductive technology (ART), Anovulation and ovulatory dysfunction 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}}