Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database.
assisted reproductive technologies
dose adjustments
infertility
ovarian stimulation
r-hFSH- alfa
Journal
Frontiers in endocrinology
ISSN: 1664-2392
Titre abrégé: Front Endocrinol (Lausanne)
Pays: Switzerland
ID NLM: 101555782
Informations de publication
Date de publication:
2021
2021
Historique:
received:
15
07
2021
accepted:
16
11
2021
entrez:
27
12
2021
pubmed:
28
12
2021
medline:
17
2
2022
Statut:
epublish
Résumé
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. 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 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 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.
Identifiants
pubmed: 34956077
doi: 10.3389/fendo.2021.742089
pmc: PMC8696034
doi:
Substances chimiques
Follicle Stimulating Hormone, Human
0
Recombinant Proteins
0
follitropin alfa
0
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
742089Informations de copyright
Copyright © 2021 Mahony, Hayward, Mottla, Richter, Beall, Ball and D’Hooghe.
Déclaration de conflit d'intérêts
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.
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