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Follicle-Stimulating Hormone Biological Products: Does Potency Predict Clinical Efficacy?
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 man...
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Published in: | International journal of molecular sciences 2023-05, Vol.24 (10), p.9020 |
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description | 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. |
doi_str_mv | 10.3390/ijms24109020 |
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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. 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Licensee MDPI, Basel, Switzerland. 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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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.</description><subject>Acids</subject><subject>Biological activity</subject><subject>Biological Products</subject><subject>Chorionic gonadotropin</subject><subject>Chorionic Gonadotropin - pharmacology</subject><subject>Female</subject><subject>Follicle Stimulating Hormone - pharmacology</subject><subject>Follicle Stimulating Hormone, Human - pharmacology</subject><subject>Follicle-stimulating hormone</subject><subject>Follicles</subject><subject>Glycoproteins</subject><subject>Gonadotropin</subject><subject>Gonadotropins</subject><subject>Heterogeneity</subject><subject>Hormones</subject><subject>Human reproduction</subject><subject>Humans</subject><subject>Infertility</subject><subject>Luteinizing hormone</subject><subject>Ovaries</subject><subject>Pharmacodynamics</subject><subject>Pharmacokinetics</subject><subject>Physiology</subject><subject>Pituitary (anterior)</subject><subject>Pituitary gland</subject><subject>Proteins</subject><subject>Reproduction</subject><subject>Review</subject><subject>Signal transduction</subject><subject>Treatment Outcome</subject><subject>Urine</subject><issn>1422-0067</issn><issn>1661-6596</issn><issn>1422-0067</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><recordid>eNptksFvFSEQxonR2Fq9eTabePHg1mFgYddLU5-tNWliE_XgibAs--SFhQq7Ju-_l2drfTWGw5Dh930wwxDynMIxYx28cZspI6fQAcIDckg5Yg0g5MO9_QF5kvMGABk23WNywCRyYIIfkm_n0XtnvK0_z25avJ5dWFcXMU0x2Oqdiz6undG-ukpxWMyc31bvo83VVZxtMNuStoMzc7XyLvzmzsaxRLM9eUoejdpn--w2HpGv52dfVhf15acPH1enl7XhLcy1HEVvUQ7UUNQoQFPWNqanVAjZNx1nINgoLdhBN1LQQcquF0YOLbZNU1TsiJzc-F4v_WQHY8OctFfXyU06bVXUTt0_Ce67WsefigLStm3a4vDq1iHFH4vNs5pcNtZ7HWxcssIWASiXYoe-_AfdxCWFUl-haHkto5z_pdbaW-XCGMvFZmeqTmWDHHnHsVDH_6HKGuzkTGn_6Er-nuD1jcCkmHOy412RFNRuFtT-LBT8xX5j7uA_n89-AXpjrb4</recordid><startdate>20230519</startdate><enddate>20230519</enddate><creator>Lispi, Monica</creator><creator>Humaidan, Peter</creator><creator>Bousfield, George R</creator><creator>D'Hooghe, Thomas</creator><creator>Ulloa-Aguirre, Alfredo</creator><general>MDPI AG</general><general>MDPI</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-5632-7606</orcidid><orcidid>https://orcid.org/0000-0002-9532-3886</orcidid><orcidid>https://orcid.org/0000-0002-9920-3208</orcidid></search><sort><creationdate>20230519</creationdate><title>Follicle-Stimulating Hormone Biological Products: Does Potency Predict Clinical Efficacy?</title><author>Lispi, Monica ; Humaidan, Peter ; Bousfield, George R ; D'Hooghe, Thomas ; Ulloa-Aguirre, Alfredo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c480t-7f6be27d1c12a260a1385cb11667b5943063f7e0eda5761d779b6c7d82855d1c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Acids</topic><topic>Biological activity</topic><topic>Biological Products</topic><topic>Chorionic gonadotropin</topic><topic>Chorionic Gonadotropin - pharmacology</topic><topic>Female</topic><topic>Follicle Stimulating Hormone - pharmacology</topic><topic>Follicle Stimulating Hormone, Human - pharmacology</topic><topic>Follicle-stimulating hormone</topic><topic>Follicles</topic><topic>Glycoproteins</topic><topic>Gonadotropin</topic><topic>Gonadotropins</topic><topic>Heterogeneity</topic><topic>Hormones</topic><topic>Human reproduction</topic><topic>Humans</topic><topic>Infertility</topic><topic>Luteinizing hormone</topic><topic>Ovaries</topic><topic>Pharmacodynamics</topic><topic>Pharmacokinetics</topic><topic>Physiology</topic><topic>Pituitary (anterior)</topic><topic>Pituitary gland</topic><topic>Proteins</topic><topic>Reproduction</topic><topic>Review</topic><topic>Signal transduction</topic><topic>Treatment Outcome</topic><topic>Urine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lispi, Monica</creatorcontrib><creatorcontrib>Humaidan, Peter</creatorcontrib><creatorcontrib>Bousfield, George R</creatorcontrib><creatorcontrib>D'Hooghe, Thomas</creatorcontrib><creatorcontrib>Ulloa-Aguirre, Alfredo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>International journal of molecular sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lispi, Monica</au><au>Humaidan, Peter</au><au>Bousfield, George R</au><au>D'Hooghe, Thomas</au><au>Ulloa-Aguirre, Alfredo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Follicle-Stimulating Hormone Biological Products: Does Potency Predict Clinical Efficacy?</atitle><jtitle>International journal of molecular sciences</jtitle><addtitle>Int J Mol Sci</addtitle><date>2023-05-19</date><risdate>2023</risdate><volume>24</volume><issue>10</issue><spage>9020</spage><pages>9020-</pages><issn>1422-0067</issn><issn>1661-6596</issn><eissn>1422-0067</eissn><abstract>Follicle-stimulating hormone (FSH), together with luteinizing hormone (LH) and human chorionic gonadotropin (hCG), plays a fundamental role in human reproduction. 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subjects | Acids Biological activity Biological Products Chorionic gonadotropin Chorionic Gonadotropin - pharmacology Female Follicle Stimulating Hormone - pharmacology Follicle Stimulating Hormone, Human - pharmacology Follicle-stimulating hormone Follicles Glycoproteins Gonadotropin Gonadotropins Heterogeneity Hormones Human reproduction Humans Infertility Luteinizing hormone Ovaries Pharmacodynamics Pharmacokinetics Physiology Pituitary (anterior) Pituitary gland Proteins Reproduction Review Signal transduction Treatment Outcome Urine |
title | Follicle-Stimulating Hormone Biological Products: Does Potency Predict Clinical Efficacy? |
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