{"id":"gonal-f-pen","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":"Gonal-f mimics the natural FSH hormone by binding to FSH receptors on ovarian granulosa cells, promoting the growth and maturation of ovarian follicles. This leads to increased estrogen production and development of multiple follicles suitable for egg retrieval during assisted reproductive procedures. The pen formulation provides a convenient subcutaneous delivery method for patients requiring daily injections during ovarian stimulation cycles.","oneSentence":"Gonal-f is a recombinant human follicle-stimulating hormone (FSH) that stimulates ovarian follicle development and maturation in women undergoing fertility treatment.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:14:15.117Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ovarian stimulation in women undergoing assisted reproductive technology (ART) procedures"},{"name":"Anovulation or oligo-ovulation in women seeking fertility treatment"}]},"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, 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University","startDate":"2024-09-01","conditions":"Infertility","enrollment":300},{"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":"NCT03228680","phase":"PHASE3","title":"Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2017-07-29","conditions":"Infertility","enrollment":373},{"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 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Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2010-06","conditions":"Infertility","enrollment":1424},{"nctId":"NCT04134130","phase":"NA","title":"The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer","status":"COMPLETED","sponsor":"Lund University","startDate":"2019-09-16","conditions":"Prostate Cancer Recurrent","enrollment":33},{"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":"NCT03506243","phase":"PHASE3","title":"Randomized Controlled Study of Comparing Follitrope Versus Gonal-f in Chinese Infertility Women.","status":"COMPLETED","sponsor":"Hangzhou YuYuan Bioscience Technology Co., Ltd.","startDate":"2015-04","conditions":"Infertility, Female","enrollment":451},{"nctId":"NCT01183143","phase":"PHASE3","title":"Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2004-05-11","conditions":"Infertility, Ovulation Induction, In-Vitro Fertilization","enrollment":215},{"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":"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":"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":"NCT01075854","phase":"","title":"An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2009-04","conditions":"Multifollicular Stimulation","enrollment":1539},{"nctId":"NCT01081639","phase":"PHASE3","title":"To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2003-11","conditions":"Infertility, Ovulation Induction","enrollment":34},{"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":"NCT01125462","phase":"","title":"A Post Marketing Assessment of Gonal f Solution for Injection in a Prefilled Pen for Follicular Stimulation in in Vitro Fertilisation/Embryo Transfer (IVF-ET) Cycles","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2011-02","conditions":"Infertility","enrollment":61},{"nctId":"NCT01080729","phase":"","title":"An Observational Study to Compare the Dose of Gonal-fTM FbM Prescribed by the Doctor With the Recommendation of 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Used for Ovarian stimulation in women undergoing assisted reproductive technology (ART) procedures, Anovulation or oligo-ovulation in women seeking fertility treatment.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}