Evaluation of the Safety and Effectiveness of Follitropin Alfa and Lutropin Alfa in Korean Patients with Severe Luteinizing Hormone and Follicle-Stimulating Hormone Deficiency: A Real-World, Prospective, Multicenter, Observational Post-Marketing Surveillance Study

Evaluation of the Safety and Effectiveness of Follitropin Alfa and Lutropin Alfa in Korean Patients with Severe Luteinizing Hormone and Follicle-Stimulating Hormone Deficiency: A Real-World, Prospective, Multicenter, Observational Post-Marketing Surveillance Study | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 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Data may be preliminary. 18 March 2025 V1 Latest version Share on Evaluation of the Safety and Effectiveness of Follitropin Alfa and Lutropin Alfa in Korean Patients with Severe Luteinizing Hormone and Follicle-Stimulating Hormone Deficiency: A Real-World, Prospective, Multicenter, Observational Post-Marketing Surveillance Study Authors : Young-Je Kang , Chung-Hoon Kim , Aera Han , Dongho Suh , Gwang-Mun Yang , Hee-Sun Lee , Chang Young Hur , … Show All … , Chan Park , Bum-Chae Choi , Miranda Hickey , Hyun-Sun Kong , Sungjin Ahn , and Beom Jun Seo [email protected] Show Fewer Authors Info & Affiliations https://doi.org/10.22541/au.174233361.15404903/v1 264 views 120 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are essential for reproductive health. Patients with severe LH and FSH deficiencies require exogenous hormone therapy to restore fertility. The combination of recombinant FSH (follitropin alfa, r-hFSH) and recombinant LH (lutropin alfa, r-hLH) in a 2:1 IU ratio addresses these deficiencies and stimulates follicular development in women undergoing assisted reproductive technologies. This prospective, observational, real-world post-marketing surveillance study was conducted from August 2011 to May 2018 at 24 sites in Korea to evaluate the safety and effectiveness of r-hFSH/r-hLH in patients with severe LH and FSH deficiencies. Safety was assessed by the incidence of adverse events (AEs) and adverse drug reactions (ADRs), while effectiveness was evaluated based on follicular growth and pregnancy rates. A total of 600 patients were included in the safety analysis, with 532 in the effectiveness evaluation. The mean age was 34.58 years, and the mean LH and FSH levels were 0.70 IU/L and 3.25 IU/L, respectively. The overall incidence of AEs was 2.7%, with ADRs reported in 2.2%. Ovarian hyperstimulation syndrome (OHSS) occurred in 1.3% of patients. Notably, 99.25% of patients achieved mature follicular growth, and the pregnancy rate was 42.67%. This study identified no new safety concerns, demonstrating the effectiveness of r-hFSH/r-hLH in treating severe LH and FSH deficiencies in Korean women. These findings highlight the value of r-hFSH/r-hLH in personalized fertility treatments. Clinical Trial Number NCT01416987 (Registration Date: July 1, 2014) Supplementary Material File (pds-25-0197-file001.docx) Download 83.28 KB File (pds-25-0197-file002.docx) Download 46.80 KB Information & Authors Information Version history V1 Version 1 18 March 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords follitropin alfa hypogonadotropic hypogonadism lutropin alfa post-marketing surveillance real-world evidence severe luteinizing hormone deficiency Authors Affiliations Young-Je Kang Maria Fertility Hospital View all articles by this author Chung-Hoon Kim M Fertility Center View all articles by this author Aera Han CHA University View all articles by this author Dongho Suh Dongtan Jeil Women’s Hospital View all articles by this author Gwang-Mun Yang Maria Fertility Hospital View all articles by this author Hee-Sun Lee Seoul Rachel Fertility Center View all articles by this author Chang Young Hur Maria S Fertility Hospital View all articles by this author Chan Park CHA University Bundang Medical Center View all articles by this author Bum-Chae Choi Creation and Love Women’s Hospital View all articles by this author Miranda Hickey Merck Healthcare Pty Ltd View all articles by this author Hyun-Sun Kong Merck Ltd Korea View all articles by this author Sungjin Ahn Merck Ltd Korea View all articles by this author Beom Jun Seo [email protected] Merck Ltd Korea View all articles by this author Metrics & Citations Metrics Article Usage 264 views 120 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Young-Je Kang, Chung-Hoon Kim, Aera Han, et al. Evaluation of the Safety and Effectiveness of Follitropin Alfa and Lutropin Alfa in Korean Patients with Severe Luteinizing Hormone and Follicle-Stimulating Hormone Deficiency: A Real-World, Prospective, Multicenter, Observational Post-Marketing Surveillance Study. Authorea . 18 March 2025. DOI: https://doi.org/10.22541/au.174233361.15404903/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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