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Real-World Effectiveness and Safety of Recombinant Human Follicle-Stimulating Hormone (rhFSH) in Infertile Women undergoing Assisted Reproductive Technology (ART): A Korean Nationwide Cohort Study
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DOI：10.1002/cpt.70136.png)
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Abstract
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Despite widespread rhFSH use in infertile women undergoing ART, real-world comparative data on its effectiveness and safety across different rhFSH types remain limited. Using the HIRA claims database, we included 10,684 women aged 20–39 with infertility (2016–2021) who used only rhFSH in their first in vitro fertilization–embryo transfer (IVF-ET). Outcome variables comprised effectiveness (≥ 11 oocytes retrieved, pregnancy rates and live birth rate) and safety (ectopic pregnancy, miscarriage, preterm birth and ovarian hyperstimulation syndrome [OHSS]) in the whole cohort, further categorized into follitropin and other rhFSH. Baseline characteristics were described, and relative risks (RR) with 95% confidence intervals (CI) were estimated using a generalized linear model, adjusting for age and imbalanced variables. Of 10,684 patients prescribed rhFSH, 7.1% were aged 20–29, 41.6% were 30–34, and 51.3% were 35–39. ICSI was utilized in 57.7% of cycles, and 76.8% used the GnRH antagonist protocol. The live birth rate was 38.8%, and the OHSS rate was 5.9%. Comparing baseline characteristics of the follitropin (n = 2,594) and other rhFSH group (n = 8,090), ICSI (62.2% vs. 56.3%) and GnRH antagonist protocol (81.3% vs. 75.3%) were more common in the follitropin group. Women who received follitropin were more likely to have ≥ 11 oocytes retrieved (adjusted RR, 1.09; 95% CI: 1.02–1.16) and less likely to have OHSS (adjusted RR, 0.73; 95% CI: 0.60–0.90). These findings provide real-world evidence supporting rhFSH effectiveness and safety in fresh IVF cycles, with follitropin potentially offering advantages in oocyte retrieval and reduced OHSS rates.
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