{"id":"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 that promotes follicular development during the menstrual cycle. By activating FSH receptors on ovarian granulosa cells, it increases estrogen production and facilitates the recruitment and growth of multiple follicles. This is used therapeutically to induce controlled ovarian hyperstimulation for assisted reproductive technologies.","oneSentence":"Recombinant follicle-stimulating hormone (r-FSH) stimulates the growth and maturation of ovarian follicles in women by binding to FSH receptors on granulosa cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:36:55.680Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF)"},{"name":"Anovulation and ovulatory disorders in women"}]},"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":"NCT06778733","phase":"EARLY_PHASE1","title":"Effectiveness of Low Dose Gonadotropin Stimulation Protocol Vs High Dose Gonadotropin Protocol in Poor Responders","status":"COMPLETED","sponsor":"University of Athens","startDate":"2022-01-01","conditions":"Female Infertility","enrollment":22},{"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":"NCT04724486","phase":"PHASE4","title":"Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI","status":"COMPLETED","sponsor":"Damascus University","startDate":"2020-08-22","conditions":"In Vitro Fertilization, Intracytoplasmic Sperm Injection, Infertility","enrollment":50},{"nctId":"NCT04724343","phase":"PHASE4","title":"Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes.","status":"COMPLETED","sponsor":"Damascus University","startDate":"2019-12-22","conditions":"In Vitro Fertilization, Intracytoplasmic Sperm Injection, Infertility","enrollment":50},{"nctId":"NCT04727684","phase":"PHASE4","title":"Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI","status":"COMPLETED","sponsor":"Damascus University","startDate":"2020-08-22","conditions":"In Vitro Fertilization, Infertility, Intracytoplasmic Sperm Injection","enrollment":50},{"nctId":"NCT04727671","phase":"PHASE4","title":"Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.","status":"COMPLETED","sponsor":"Damascus University","startDate":"2019-12-22","conditions":"In Vitro Fertilization, Intracytoplasmic Sperm Injection, Infertility","enrollment":50},{"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":"NCT03252223","phase":"PHASE4","title":"Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2017-10-02","conditions":"Polycystic Ovary Syndrome, Healthy, Anovulation","enrollment":33},{"nctId":"NCT01297465","phase":"PHASE3","title":"PERgoveriS In Stratified Treatment for Assisted Reproductive Technique","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2011-05-31","conditions":"Assisted Reproductive Techniques, Reproductive Technology, Assisted","enrollment":202},{"nctId":"NCT01794208","phase":"PHASE2","title":"Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®","status":"COMPLETED","sponsor":"Glycotope GmbH","startDate":"2013-01-08","conditions":"Infertility","enrollment":267},{"nctId":"NCT01416987","phase":"","title":"A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2011-08-14","conditions":"Infertility","enrollment":600},{"nctId":"NCT03686852","phase":"NA","title":"Effect of Recombinant Follicular Stimulating Hormone (FSH) Dosing Following Cori-follitropin Alfa","status":"UNKNOWN","sponsor":"Universitair Ziekenhuis Brussel","startDate":"2019-05-01","conditions":"Infertility","enrollment":261},{"nctId":"NCT01112358","phase":"PHASE2","title":"Lutropin Alfa in Women at Risk of Poor Response","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2005-12-07","conditions":"Ovarian Stimulation","enrollment":58},{"nctId":"NCT02607293","phase":"","title":"A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2015-12-31","conditions":"Polycystic Ovary Syndrome","enrollment":1064},{"nctId":"NCT00989781","phase":"NA","title":"Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2009-09","conditions":"Polycystic Ovary Syndrome","enrollment":41},{"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":"NCT01110707","phase":"PHASE2","title":"A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2005-01-10","conditions":"Infertility, Ovulation Induction","enrollment":131},{"nctId":"NCT01687712","phase":"PHASE3","title":"Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF","status":"COMPLETED","sponsor":"Fertility Biotech AG","startDate":"2013-11-25","conditions":"Infertility","enrollment":1100},{"nctId":"NCT02047227","phase":"PHASE3","title":"Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2014-01-31","conditions":"Infertility","enrollment":939},{"nctId":"NCT02454556","phase":"PHASE3","title":"A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART","status":"COMPLETED","sponsor":"Gema Biotech S.A.","startDate":"2015-04","conditions":"Infertility","enrollment":106},{"nctId":"NCT01871532","phase":"PHASE4","title":"Low-dose Gonal-f® in Ovulation Induction","status":"TERMINATED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2013-07","conditions":"Infertility, Monofollicular Development","enrollment":24},{"nctId":"NCT01121666","phase":"PHASE3","title":"Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment","status":"COMPLETED","sponsor":"Finox AG","startDate":"2010-06","conditions":"Infertility","enrollment":460},{"nctId":"NCT01653743","phase":"PHASE3","title":"Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2012-09","conditions":"Anovulation, Oligo-ovulation, Hypothalamic-pituitary Dysfunction","enrollment":81},{"nctId":"NCT01497197","phase":"PHASE3","title":"A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique","status":"TERMINATED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2012-05","conditions":"Infertility, Fertility, Follicle Stimulating Hormone Deficiency","enrollment":174},{"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":"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":"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":"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":"NCT01504139","phase":"PHASE4","title":"The Luteal Phase After GnRHa Trigger - a Proof of Concept Study","status":"COMPLETED","sponsor":"Regionshospitalet Viborg, Skive","startDate":"2012-01","conditions":"Progesterone Levels, Infertility","enrollment":93},{"nctId":"NCT01100333","phase":"","title":"GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2008-04","conditions":"Infertility","enrollment":2552},{"nctId":"NCT01115725","phase":"","title":"A Study to Evaluate the Ease of Use, Local Tolerance, Safety and Effectiveness of Gonal-f® (Filled-by-mass in a Prefilled Pen)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2005-11","conditions":"Infertility","enrollment":76},{"nctId":"NCT01111084","phase":"","title":"A Prospective, Multi-centric Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2004-03","conditions":"Ovulation Induction","enrollment":410},{"nctId":"NCT01080729","phase":"","title":"An Observational Study to Compare the Dose of Gonal-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of Gonal-fTM FbM Pen","status":"TERMINATED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2009-02","conditions":"Multifollicular Stimulation","enrollment":25},{"nctId":"NCT00298025","phase":"PHASE4","title":"A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation","status":"COMPLETED","sponsor":"EMD Serono","startDate":"2003-09","conditions":"Infertile Women Undergoing Assisted Reproductive Technology (ART)","enrollment":185},{"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":"NCT00505752","phase":"PHASE2","title":"Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2007-01","conditions":"Infertility","enrollment":520},{"nctId":"NCT00553514","phase":"PHASE2","title":"AS900672-Enriched in Ovulation Induction","status":"TERMINATED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2007-12","conditions":"Ovulation Induction","enrollment":71},{"nctId":"NCT00829244","phase":"PHASE4","title":"CONSORT Randomized Controlled Trial in Assisted Reproductive Technology","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2008-08","conditions":"Infertility","enrollment":200},{"nctId":"NCT01185704","phase":"PHASE3","title":"Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2008-11","conditions":"Polycystic Ovarian Syndrome","enrollment":136},{"nctId":"NCT01735422","phase":"PHASE2","title":"A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"1999-12","conditions":"Infertility","enrollment":67},{"nctId":"NCT01196143","phase":"","title":"A Study to Evaluate the Baseline Follicle Stimulating Hormone, Ovarian Volume and Antral Follicle Count as Prognostic Factors of the Outcome of In-vitro Fertilisation/Intracytosolic Sperm Injection in Infertile Patients Receiving Gonal f for Controlled Ovarian Hyperstimulation","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2008-10","conditions":"Infertility","enrollment":356},{"nctId":"NCT01185782","phase":"PHASE3","title":"SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2007-02","conditions":"Infertility, Ovulation Induction","enrollment":300},{"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":"NCT01084265","phase":"PHASE3","title":"A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2004-02","conditions":"Hypogonadism","enrollment":31},{"nctId":"NCT00230815","phase":"PHASE3","title":"A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction","status":"COMPLETED","sponsor":"EMD Serono","startDate":"2004-07","conditions":"Infertility","enrollment":62},{"nctId":"NCT01339299","phase":"PHASE4","title":"Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)","status":"COMPLETED","sponsor":"Regionshospitalet Viborg, Skive","startDate":"2009-10","conditions":"Controlled Ovarian Stimulation, Infertility","enrollment":100},{"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":"NCT01152866","phase":"","title":"An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART)","status":"COMPLETED","sponsor":"EMD Serono","startDate":"2003-12","conditions":"Ovulation Induction, Infertility","enrollment":3},{"nctId":"NCT01223079","phase":"NA","title":"Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)","status":"COMPLETED","sponsor":"Reproductive Medicine Associates of New Jersey","startDate":"2005-12","conditions":"Outcome During r-hFSH Stimulation, Outcome During r-hFSH and r-hLH Stimulation","enrollment":20},{"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":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"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":"r-FSH (Gonal-f)","genericName":"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 by binding to FSH receptors on granulosa cells. Used for Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF), Anovulation and ovulatory disorders in women.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}