Follicle-stimulating hormone biological products: Does potency predict clinical efficacy?

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Issue Date
2023-05-19
Embargo End Date
Authors
Lispi, Monica
Humaidan, Peter
Bousfield, George R.
D'Hooghe, Thomas
Ulloa-Aguirre, Alfredo
Advisor
Citation

Lispi, M.; Humaidan, P.; Bousfield, G.R.; D'Hooghe, T.; Ulloa-Aguirre, A. Follicle-Stimulating Hormone Biological Products: Does Potency Predict Clinical Efficacy? Int. J. Mol. Sci. 2023, 24, 9020. https://doi.org/10.3390/ijms24109020

Abstract

Follicle-stimulating hormone (FSH), together with luteinizing hormone (LH) and human chorionic gonadotropin (hCG), plays a fundamental role in human reproduction. The discovery of FSH and other gonadotropins was a defining moment in our understanding of reproduction and led to the development of many treatments for infertility. In this regard, exogenous FSH has been used to treat infertility in women for decades. Today, several recombinant and highly purified urinary forms of FSH are used in medically assisted reproduction (MAR). However, differences in the macro- and micro-heterogeneity of FSH result in a variety of FSH glycoforms, with glycoform composition determining the bioactivity (or potency), pharmacokinetic/pharmacodynamic (PK/PD) profiles, and clinical efficacy of the different forms of FSH. This review illustrates how the structural heterogeneity of FSH glycoforms affects the biological activity of human FSH products, and why potency does not predict effects in humans in terms of PK, PD, and clinical response.

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This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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