Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database.
| Autor: | Mahony MC; North America Medical Affairs, EMD Serono, Inc. (an affiliate of Merck KGaA), Rockland, MA, United States., Hayward B; North America Medical Affairs, EMD Serono, Inc. (an affiliate of Merck KGaA), Rockland, MA, United States., Mottla GL; Obstetrics and Gynecology, Reproductive Endocrinology and Infertility, Shady Grove Fertility Reproductive Science Center, Rockville, MD, United States., Richter KS; Fertility Science Consulting, Silver Spring, MD, United States., Beall S; Obstetrics and Gynecology, Reproductive Endocrinology and Infertility, Shady Grove Fertility Reproductive Science Center, Rockville, MD, United States., Ball GD; Seattle Reproductive Medicine, Seattle, WA, United States., D'Hooghe T; Merck Healthcare KGaA, Darmstadt, Germany.; Reproductive Medicine, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Leuven, Belgium.; Department of Obstetrics and Gynecology, Yale University, New Haven, CT, United States. |
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| Jazyk: | angličtina |
| Zdroj: | Frontiers in endocrinology [Front Endocrinol (Lausanne)] 2021 Dec 09; Vol. 12, pp. 742089. Date of Electronic Publication: 2021 Dec 09 (Print Publication: 2021). |
| DOI: | 10.3389/fendo.2021.742089 |
| Abstrakt: | Purpose: To determine the pattern of dose adjustment of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) during ovarian stimulation (OS) for assisted reproductive technology (ART) in a real-world setting. Methods: This was an observational, retrospective analysis of data from an electronic de-identified medical records database including 39 clinics in the USA. Women undergoing OS for ART (initiated 2009-2016) with r-hFSH-alfa (Gonal-f ® or Gonal-f RFF Redi-ject ® ) were included. Assessed outcomes were patients' baseline characteristics and dosing characteristics/cycle. Results: Of 33,962 ART cycles, 13,823 (40.7%) underwent dose adjustments: 23.4% with ≥1 dose increase, 25.4% with ≥1 dose decrease, and 8.1% with ≥1 increase and ≥1 decrease. Patients who received dose adjustments were younger (mean [SD] age 34.8 [4.58] years versus 35.9 [4.60] years, p<0.0001) and had lower BMI (25.1 [5.45] kg/m 2 versus 25.5 [5.45] kg/m 2 , p<0.0001) than those who received a constant dose. The proportion of patients with non-normal ovarian reserve was 38.4% for those receiving dose adjustment versus 51.9% for those with a constant dose. The mean (SD) number of dose changes/cycle was 1.61 (0.92) for cycles with any dose adjustment, 1.72 (1.03) for cycles with ≥1 dose increase, 2.77 (1.00) for cycles with ≥1 dose increase and ≥1 decrease (n=2,755), and 1.88 (1.03) for cycles with ≥1 dose decrease. Conclusions: Dose adjustment during OS is common in clinical practice in the USA and occurred more often in younger versus older patients, those with a high versus non-normal ovarian reserve or those with ovulation disorders/polycystic ovary syndrome versus other primary diagnoses of infertility. Competing Interests: BH is an employee of EMD Serono, Inc., Rockland,MA, USA (an affiliate of Merck KGaA). TD’H is an employee of Merck KGaA, Darmstadt, Germany. At the time of the analysis, MM was an employee of EMD Serono, Inc., Rockland, MA, USA (an affiliate of Merck KGaA). KR is Founder and Chief Scientist of the company Fertility Science Consulting. This study was sponsored by EMD Serono Inc., an affiliate of Merck KGaA (CrossRef Funder ID: 10.13039/100004755). The sponsor designed and approved the study, took part in data analysis, and contributed to the data interpretation and final draft of the manuscript. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. (Copyright © 2021 Mahony, Hayward, Mottla, Richter, Beall, Ball and D’Hooghe.) |
| Databáze: | MEDLINE |
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