Fine-tuning the dose of recombinant human follicle-stimulating hormone alfa to individualize treatment in ovulation induction and ovarian stimulation cycles: a real-world database analysis.

Autor:	Martini AE; National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States., Beall S; Reproductive Endocrinology and Infertility Department, Shady Grove Fertility Center, Rockville, MD, United States., Ball GD; Seattle Reproductive Medicine Center, Seattle, WA, United States., Hayward B; US Medical Affairs Fertility, EMD Serono, Inc., Rockland, MA, United States., D'Hooghe T; Global Medical Affairs Fertility, Research and Development, Merck Healthcare KGaA, Darmstadt, Germany.; Research Group Reproductive Medicine, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Leuven, Belgium.; Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, CT, United States.; Gynecologic and Obstetric Investigation, Basel, Switzerland., Mahony MC; Independent Scientific Affairs Consultant, Virginia Beach, VA, United States., Collares F; US Medical Affairs Fertility, EMD Serono, Inc., Rockland, MA, United States., Catherino AB; US Medical Affairs Fertility, EMD Serono, Inc., Rockland, MA, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in endocrinology [Front Endocrinol (Lausanne)] 2023 Sep 01; Vol. 14, pp. 1195632. Date of Electronic Publication: 2023 Sep 01 (Print Publication: 2023).
DOI:	10.3389/fendo.2023.1195632
Abstrakt:	Introduction: Fine-tuning of injectable gonadotropin doses during ovulation induction (OI) or ovarian stimulation (OS) treatment cycles with the aim of using doses low enough to minimize the risk of excessive ovarian response while maintaining optimal efficacy may be facilitated by using an adjustable-dose pen injector. We examined the incidence and magnitude of individualized gonadotropin dose adjustments made during cycles of OI or OS, followed by either timed intercourse or intrauterine insemination, with or without oral medications, and assessed the relationship between patient characteristics and dosing changes using real-world evidence. Methods: This was an observational, retrospective cohort study using electronic medical records from a large US database of fertility centers. Data from patients who had undergone a first recombinant human follicle stimulating hormone alfa (r-hFSH-alfa/follitropin alfa) treated OI/OS cycle followed by timed intercourse or intrauterine insemination between 2015 and 2016 were included. Percentages of OI/OS cycles involving r-hFSH-alfa dose adjustments (in increments of ±12.5 IU or greater) with or without oral medications (clomiphene citrate or letrozole) were analyzed. Results: Of 2,832 OI/OS cycles involving r-hFSH-alfa administration, 74.6% included combination treatment with orals; 25.4% involved r-hFSH-alfa alone. As expected, the starting dose of r-hFSH-alfa was lower for cycles that used r-hFSH-alfa with orals than r-hFSH-alfa only cycles (mean [SD]: 74.2 [39.31] vs 139.3 [115.10] IU). Dose changes occurred in 13.7% of r-hFSH-alfa with orals versus 43.9% of r-hFSH-alfa only cycles. Dose adjustment magnitudes ranged from ±12.5 IU to ±450 IU. The smallest adjustment magnitudes (±12.5 IU and ±25 IU) were used frequently and more often for dose increases than for dose decreases. For r-hFSH-alfa with orals and r-hFSH-alfa only cycles, the smallest adjustments were used in 53.5% and 64.5% of cycles with dose increases and in 35.7% and 46.8% of cycles with dose decreases, respectively. Discussion: In OI/OS cycles followed by timed intercourse or intrauterine insemination, r-hFSH-alfa dose adjustments were frequent. In cycles that included orals, r-hFSH-alfa starting doses were lower and dose changes were fewer than with r-hFSH-alfa alone. Smaller dose adjustments facilitate individualized treatment with the goal of reducing the risks of multiple gestation, cycle cancellation, and ovarian hyperstimulation syndrome. Competing Interests: FC and AC are employed by EMD Serono, Inc., Rockland, MA, USA. BH and MM were employed by EMD Serono, Inc., Rockland, MA, USA during some or all of the work leading to this manuscript. TD’H is employed by Merck Healthcare KGaA, Darmstadt, Germany. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 Martini, Beall, Ball, Hayward, D’Hooghe, Mahony, Collares and Catherino.)
Databáze:	MEDLINE
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