Young-Je Kang

and 12 more

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 human FSH (follitropin alfa, r-hFSH) and recombinant human 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)