Abstract

Purpose: This post-marketing surveillance study evaluated the real-world safety and descriptive outcomes of a fixed 2:1 recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) combination among Korean women undergoing assisted reproductive technology with severe LH and FSH deficiency (baseline endogenous serum LH < 1.2 IU/L). Methods: A prospective, multicenter, observational study was conducted across 24 Korean fertility centers between August 2011 and May 2018. Safety outcomes included adverse events (AEs), adverse drug reactions (ADRs), and ovarian hyperstimulation syndrome (OHSS). Descriptive outcomes included endpoint-specific evaluable sets for follicular response and ultrasound-confirmed clinical pregnancy. Analyses were performed in safety (n = 600), follicular-response evaluable (n = 537), and pregnancy-evaluable (n = 486) sets. Results: Among patients in the safety set (mean age, 34.6 years), AEs occurred in 2.7% (16/600; 95% confidence interval [CI], 1.6–4.3), ADRs in 2.2% (13/600; 95% CI, 1.3–3.7), and OHSS in 1.3% (8/600; 95% CI, 0.7–2.6), including one severe case. In the follicular-response evaluable set, follicular response (≥1 follicle ≥17 mm) occurred in 99.3% (533/537; 95% CI, 98.1–99.7). In the pregnancy-evaluable set, clinical pregnancy occurred in 42.0% (204/486; 95% CI, 37.7–46.4), biochemical-only pregnancies in 3.1% (15/486; 95% CI, 1.9–5.0), and total pregnancies (clinical + biochemical-only, reported descriptively) in 45.1% (219/486; 95% CI, 40.7–49.5). Conclusions: In this historically constrained post-marketing surveillance cohort, the fixed 2:1 r-hFSH and r-hLH combination showed a favorable post-marketing safety profile and provided descriptive outcome information within endpoint-specific evaluable sets in women meeting the severe LH-deficiency criterion.

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