A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol
Identifieur interne : 001835 ( Istex/Corpus ); précédent : 001834; suivant : 001836A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol
Auteurs : P. Devroey ; R. Boostanfar ; N. P. Koper ; B. M. J. L. Mannaerts ; P. C. Ijzerman-Boon ; B. C. J. M. FauserSource :
- Human Reproduction [ 0268-1161 ] ; 2009-12.
Abstract
BACKGROUND Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation. METHODS In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 g corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol. RESULTS The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9 for the corifollitropin alfa group and 38.1 for rFSH were achieved, with an estimated non-significant difference of 0.9 [95 confidence interval (CI): 3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulusoocyte-complexes compared with rFSH [estimated difference 1.2 (95 CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7, respectively P 0.15). CONCLUSION Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.
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DOI: 10.1093/humrep/dep291
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Koper</name><affiliation><mods:affiliation>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Mannaerts, B M J L" sort="Mannaerts, B M J L" uniqKey="Mannaerts B" first="B. M. J. L." last="Mannaerts">B. M. J. L. Mannaerts</name><affiliation><mods:affiliation>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: b.mannaerts@spcorp.com</mods:affiliation></affiliation></author><author><name sortKey="Ijzerman Boon, P C" sort="Ijzerman Boon, P C" uniqKey="Ijzerman Boon P" first="P. C." last="Ijzerman-Boon">P. C. Ijzerman-Boon</name><affiliation><mods:affiliation>Research Data and Quantitative Sciences, Schering-Plough Research Institute, Oss, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Fauser, B C J M" sort="Fauser, B C J M" uniqKey="Fauser B" first="B. C. J. M." last="Fauser">B. C. J. M. 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Devroey</name><affiliation><mods:affiliation>Center for Reproductive Medicine, UZ Brussel, Brussels, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Boostanfar, R" sort="Boostanfar, R" uniqKey="Boostanfar R" first="R." last="Boostanfar">R. Boostanfar</name><affiliation><mods:affiliation>Huntington Reproductive Center, Westlake Village, CA, USA</mods:affiliation></affiliation></author><author><name sortKey="Koper, N P" sort="Koper, N P" uniqKey="Koper N" first="N. P." last="Koper">N. P. Koper</name><affiliation><mods:affiliation>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Mannaerts, B M J L" sort="Mannaerts, B M J L" uniqKey="Mannaerts B" first="B. M. J. L." last="Mannaerts">B. M. J. L. Mannaerts</name><affiliation><mods:affiliation>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: b.mannaerts@spcorp.com</mods:affiliation></affiliation></author><author><name sortKey="Ijzerman Boon, P C" sort="Ijzerman Boon, P C" uniqKey="Ijzerman Boon P" first="P. C." last="Ijzerman-Boon">P. C. Ijzerman-Boon</name><affiliation><mods:affiliation>Research Data and Quantitative Sciences, Schering-Plough Research Institute, Oss, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Fauser, B C J M" sort="Fauser, B C J M" uniqKey="Fauser B" first="B. C. J. M." last="Fauser">B. C. J. M. Fauser</name><affiliation><mods:affiliation>Department of Reproductive Medicine and Gynecology, University Medical Center, Utrecht, The Netherlands</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Human Reproduction</title><idno type="ISSN">0268-1161</idno><idno type="eISSN">1460-2350</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2009-12">2009-12</date><biblScope unit="volume">24</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="3063">3063</biblScope><biblScope unit="page" to="3072">3072</biblScope></imprint><idno type="ISSN">0268-1161</idno></series><idno type="istex">82375B78B6F4D81A02A163136FCE4CAA43E4ECB0</idno><idno type="DOI">10.1093/humrep/dep291</idno><idno type="ArticleID">dep291</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0268-1161</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">BACKGROUND Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation. METHODS In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 g corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol. RESULTS The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9 for the corifollitropin alfa group and 38.1 for rFSH were achieved, with an estimated non-significant difference of 0.9 [95 confidence interval (CI): 3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulusoocyte-complexes compared with rFSH [estimated difference 1.2 (95 CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7, respectively P 0.15). CONCLUSION Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.</div></front></TEI><istex><corpusName>oup</corpusName><author><json:item><name>P. Devroey</name><affiliations><json:string>Center for Reproductive Medicine, UZ Brussel, Brussels, Belgium</json:string></affiliations></json:item><json:item><name>R. Boostanfar</name><affiliations><json:string>Huntington Reproductive Center, Westlake Village, CA, USA</json:string></affiliations></json:item><json:item><name>N.P. Koper</name><affiliations><json:string>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</json:string></affiliations></json:item><json:item><name>B.M.J.L. Mannaerts</name><affiliations><json:string>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</json:string><json:string>E-mail: b.mannaerts@spcorp.com</json:string></affiliations></json:item><json:item><name>P.C. IJzerman-Boon</name><affiliations><json:string>Research Data and Quantitative Sciences, Schering-Plough Research Institute, Oss, The Netherlands</json:string></affiliations></json:item><json:item><name>on behalf of the ENGAGE Investigators B.C.J.M. Fauser</name><affiliations><json:string>Department of Reproductive Medicine and Gynecology, University Medical Center, Utrecht, The Netherlands</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>corifollitropin alfa</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>sustained follicle stimulant</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>FSH</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>ovarian stimulation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>IVF</value></json:item></subject><articleId><json:string>dep291</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>BACKGROUND Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation. METHODS In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 g corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol. RESULTS The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9 for the corifollitropin alfa group and 38.1 for rFSH were achieved, with an estimated non-significant difference of 0.9 [95 confidence interval (CI): 3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulusoocyte-complexes compared with rFSH [estimated difference 1.2 (95 CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7, respectively P 0.15). CONCLUSION Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.</abstract><qualityIndicators><score>9</score><pdfVersion>1.5</pdfVersion><pdfPageSize>612.283 x 790.866 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>5</keywordCount><abstractCharCount>1818</abstractCharCount><pdfWordCount>7898</pdfWordCount><pdfCharCount>49808</pdfCharCount><pdfPageCount>10</pdfPageCount><abstractWordCount>261</abstractWordCount></qualityIndicators><title>A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol</title><genre><json:string>research-article</json:string></genre><host><volume>24</volume><publisherId><json:string>humrep</json:string></publisherId><pages><last>3072</last><first>3063</first></pages><issn><json:string>0268-1161</json:string></issn><issue>12</issue><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1460-2350</json:string></eissn><title>Human Reproduction</title></host><categories><wos><json:string>OBSTETRICS & GYNECOLOGY</json:string><json:string>REPRODUCTIVE BIOLOGY</json:string></wos></categories><publicationDate>2009</publicationDate><copyrightDate>2009</copyrightDate><doi><json:string>10.1093/humrep/dep291</json:string></doi><id>82375B78B6F4D81A02A163136FCE4CAA43E4ECB0</id><score>0.21533427</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/82375B78B6F4D81A02A163136FCE4CAA43E4ECB0/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/82375B78B6F4D81A02A163136FCE4CAA43E4ECB0/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/82375B78B6F4D81A02A163136FCE4CAA43E4ECB0/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a">A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Oxford University Press</publisher><availability><p>The Author 2009. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.</p></availability><date>2009-08-14</date></publicationStmt><notesStmt><note>ENGAGE investigators: Belgium: Devroey, UZ Brusssel, Center for Reproductive Medicine, Brussels; Dhont, University Hospital Ghent, Department of Gynecology. Canada: Leader, The Ottawa Fertility Center, Ottawa, Ontario. Czech Republic: Mardesic, Sanatorium Pronatal, Prague; Mrzek, ISCARE IVF a.s., Prague. Denmark: Blaabjerg, Herlev Hospital, Fertility Clinic, Herlev. Finland: Tapanainen, Naistentautien klinikka, Oulun yliopistollinen sairaala (OYS), Oulu; Varila, Vestliitto, Tampereen klinikka, Tampere. France: Barrire, Hpital de la mre et de l'enfant, Nantes; Hedon, Hpital Arnaud de Villeneuve, Montpellier. The Netherlands: Fauser and Sterrenburg, University Medical Center, Department of Reproductive Medicine & Gynecology, Utrecht. Norway: Kahn, Sykehuset Telemark HF, Skien; Von Dring, St. Olavs Hospital HF, Trondheim. Spain: Bajo Arenas, Ginefiv, Madrid; Barri, Institut Universitari Dexeus, Barcelona; Fernndez-Snchez, IVI Sevilla, Sevilla. Sweden: Bergh, Kvinnokliniken, Sahlgrenska Universitetssjukhuset, Gteborg; Hillensj, Fertilitetscentrum, Carlanderska Sjukhuset, Gteborg. United Kingdom: Balen, Assisted Conception Unit, Leeds General Infirmary; Ledger, Assisted Conception Unit, Jessop Wing, The Halllamshire Hospital, Sheffield; Matthews, Bourn Hall Clinic, Cambridge. United States of America: Abuzeid, IVF Michigan, Rochester Hills (MI), Alper, Boston IVF, Waltham (MA); Boostanfar, Huntington Reproductive Center, Westlake Village (CA); Doody, Center for Assisted Reproduction, Bedford (TX); Frattarelli, Reproductive Medicine Associates of New Jersey, Morristown (NJ); Grunfeld, Reproductive Medicine Associates of New York, New York (NY); Karande, Karande and Associates SC, Hoffman Estates (IL); Kort, Reproductive Biology Associates, Atlanta (GA); Levy, Shady Grove Fertility Reproductive Science Center, Rockville (MD); Lifchez, Fertility Centers of Illinois, Chicago (IL); Pang, Reproductive Science Center of Boston, Lexington (MA); Schoolcraft, Colorado Center for Reproductive Medicine, Englewood (CO); Yeko, The Reproductive Medicine Group, Tampa (FL).</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol</title><author xml:id="author-1"><persName><forename type="first">P.</forename><surname>Devroey</surname></persName><affiliation>Center for Reproductive Medicine, UZ Brussel, Brussels, Belgium</affiliation></author><author xml:id="author-2"><persName><forename type="first">R.</forename><surname>Boostanfar</surname></persName><affiliation>Huntington Reproductive Center, Westlake Village, CA, USA</affiliation></author><author xml:id="author-3"><persName><forename type="first">N.P.</forename><surname>Koper</surname></persName><affiliation>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</affiliation></author><author xml:id="author-4"><persName><forename type="first">B.M.J.L.</forename><surname>Mannaerts</surname></persName><email>b.mannaerts@spcorp.com</email><affiliation>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</affiliation></author><author xml:id="author-5"><persName><forename type="first">P.C.</forename><surname>IJzerman-Boon</surname></persName><affiliation>Research Data and Quantitative Sciences, Schering-Plough Research Institute, Oss, The Netherlands</affiliation></author><author xml:id="author-6"><persName><forename type="first">B.C.J.M.</forename><surname>Fauser</surname></persName><note type="biography">ENGAGE investigators: Belgium: Devroey, UZ Brusssel, Center for Reproductive Medicine, Brussels; Dhont, University Hospital Ghent, Department of Gynecology. Canada: Leader, The Ottawa Fertility Center, Ottawa, Ontario. Czech Republic: Mardesic, Sanatorium Pronatal, Prague; Mrzek, ISCARE IVF a.s., Prague. Denmark: Blaabjerg, Herlev Hospital, Fertility Clinic, Herlev. Finland: Tapanainen, Naistentautien klinikka, Oulun yliopistollinen sairaala (OYS), Oulu; Varila, Vestliitto, Tampereen klinikka, Tampere. France: Barrire, Hpital de la mre et de l'enfant, Nantes; Hedon, Hpital Arnaud de Villeneuve, Montpellier. The Netherlands: Fauser and Sterrenburg, University Medical Center, Department of Reproductive Medicine & Gynecology, Utrecht. Norway: Kahn, Sykehuset Telemark HF, Skien; Von Dring, St. Olavs Hospital HF, Trondheim. Spain: Bajo Arenas, Ginefiv, Madrid; Barri, Institut Universitari Dexeus, Barcelona; Fernndez-Snchez, IVI Sevilla, Sevilla. Sweden: Bergh, Kvinnokliniken, Sahlgrenska Universitetssjukhuset, Gteborg; Hillensj, Fertilitetscentrum, Carlanderska Sjukhuset, Gteborg. United Kingdom: Balen, Assisted Conception Unit, Leeds General Infirmary; Ledger, Assisted Conception Unit, Jessop Wing, The Halllamshire Hospital, Sheffield; Matthews, Bourn Hall Clinic, Cambridge. United States of America: Abuzeid, IVF Michigan, Rochester Hills (MI), Alper, Boston IVF, Waltham (MA); Boostanfar, Huntington Reproductive Center, Westlake Village (CA); Doody, Center for Assisted Reproduction, Bedford (TX); Frattarelli, Reproductive Medicine Associates of New Jersey, Morristown (NJ); Grunfeld, Reproductive Medicine Associates of New York, New York (NY); Karande, Karande and Associates SC, Hoffman Estates (IL); Kort, Reproductive Biology Associates, Atlanta (GA); Levy, Shady Grove Fertility Reproductive Science Center, Rockville (MD); Lifchez, Fertility Centers of Illinois, Chicago (IL); Pang, Reproductive Science Center of Boston, Lexington (MA); Schoolcraft, Colorado Center for Reproductive Medicine, Englewood (CO); Yeko, The Reproductive Medicine Group, Tampa (FL).</note><affiliation>ENGAGE investigators: Belgium: Devroey, UZ Brusssel, Center for Reproductive Medicine, Brussels; Dhont, University Hospital Ghent, Department of Gynecology. Canada: Leader, The Ottawa Fertility Center, Ottawa, Ontario. Czech Republic: Mardesic, Sanatorium Pronatal, Prague; Mrzek, ISCARE IVF a.s., Prague. Denmark: Blaabjerg, Herlev Hospital, Fertility Clinic, Herlev. Finland: Tapanainen, Naistentautien klinikka, Oulun yliopistollinen sairaala (OYS), Oulu; Varila, Vestliitto, Tampereen klinikka, Tampere. France: Barrire, Hpital de la mre et de l'enfant, Nantes; Hedon, Hpital Arnaud de Villeneuve, Montpellier. The Netherlands: Fauser and Sterrenburg, University Medical Center, Department of Reproductive Medicine & Gynecology, Utrecht. Norway: Kahn, Sykehuset Telemark HF, Skien; Von Dring, St. Olavs Hospital HF, Trondheim. Spain: Bajo Arenas, Ginefiv, Madrid; Barri, Institut Universitari Dexeus, Barcelona; Fernndez-Snchez, IVI Sevilla, Sevilla. Sweden: Bergh, Kvinnokliniken, Sahlgrenska Universitetssjukhuset, Gteborg; Hillensj, Fertilitetscentrum, Carlanderska Sjukhuset, Gteborg. United Kingdom: Balen, Assisted Conception Unit, Leeds General Infirmary; Ledger, Assisted Conception Unit, Jessop Wing, The Halllamshire Hospital, Sheffield; Matthews, Bourn Hall Clinic, Cambridge. United States of America: Abuzeid, IVF Michigan, Rochester Hills (MI), Alper, Boston IVF, Waltham (MA); Boostanfar, Huntington Reproductive Center, Westlake Village (CA); Doody, Center for Assisted Reproduction, Bedford (TX); Frattarelli, Reproductive Medicine Associates of New Jersey, Morristown (NJ); Grunfeld, Reproductive Medicine Associates of New York, New York (NY); Karande, Karande and Associates SC, Hoffman Estates (IL); Kort, Reproductive Biology Associates, Atlanta (GA); Levy, Shady Grove Fertility Reproductive Science Center, Rockville (MD); Lifchez, Fertility Centers of Illinois, Chicago (IL); Pang, Reproductive Science Center of Boston, Lexington (MA); Schoolcraft, Colorado Center for Reproductive Medicine, Englewood (CO); Yeko, The Reproductive Medicine Group, Tampa (FL).</affiliation><affiliation>Department of Reproductive Medicine and Gynecology, University Medical Center, Utrecht, The Netherlands</affiliation></author></analytic><monogr><title level="j">Human Reproduction</title><idno type="pISSN">0268-1161</idno><idno type="eISSN">1460-2350</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2009-12"></date><biblScope unit="volume">24</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="3063">3063</biblScope><biblScope unit="page" to="3072">3072</biblScope></imprint></monogr><idno type="istex">82375B78B6F4D81A02A163136FCE4CAA43E4ECB0</idno><idno type="DOI">10.1093/humrep/dep291</idno><idno type="ArticleID">dep291</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2009-08-14</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>BACKGROUND Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation. METHODS In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 g corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol. RESULTS The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9 for the corifollitropin alfa group and 38.1 for rFSH were achieved, with an estimated non-significant difference of 0.9 [95 confidence interval (CI): 3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulusoocyte-complexes compared with rFSH [estimated difference 1.2 (95 CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7, respectively P 0.15). CONCLUSION Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>corifollitropin alfa</term></item><item><term>sustained follicle stimulant</term></item><item><term>FSH</term></item><item><term>ovarian stimulation</term></item><item><term>IVF</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2009-08-14">Created</change><change when="2009-12">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/82375B78B6F4D81A02A163136FCE4CAA43E4ECB0/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus oup" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="publisher-id">humrep</journal-id><journal-id journal-id-type="hwp">humrep</journal-id><journal-title>Human Reproduction</journal-title><issn pub-type="ppub">0268-1161</issn><issn pub-type="epub">1460-2350</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.1093/humrep/dep291</article-id><article-id pub-id-type="publisher-id">dep291</article-id><article-categories><subj-group subj-group-type="heading"><subject>ORIGINAL ARTICLES</subject><subj-group><subject>Infertility</subject></subj-group></subj-group></article-categories><title-group><article-title>A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Devroey</surname><given-names>P.</given-names></name><xref ref-type="aff" rid="af1">1</xref></contrib><contrib contrib-type="author"><name><surname>Boostanfar</surname><given-names>R.</given-names></name><xref ref-type="aff" rid="af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Koper</surname><given-names>N.P.</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Mannaerts</surname><given-names>B.M.J.L.</given-names></name><xref ref-type="aff" rid="af3">3</xref><xref ref-type="corresp" rid="cor1">6</xref></contrib><contrib contrib-type="author"><name><surname>IJzerman-Boon</surname><given-names>P.C.</given-names></name><xref ref-type="aff" rid="af4">4</xref></contrib><contrib contrib-type="author"><name><surname>Fauser</surname><given-names>B.C.J.M.</given-names></name><xref ref-type="aff" rid="af5">5</xref><on-behalf-of>on behalf of the ENGAGE Investigators</on-behalf-of><xref ref-type="fn" rid="FN1">†</xref></contrib></contrib-group><aff id="af1"><label>1</label><addr-line>Center for Reproductive Medicine</addr-line>, <institution>UZ Brussel</institution>, <addr-line>Brussels</addr-line>, <country>Belgium</country></aff><aff id="af2"><label>2</label><institution>Huntington Reproductive Center</institution>, <addr-line>Westlake Village, CA</addr-line>, <country>USA</country></aff><aff id="af3"><label>3</label><addr-line>Global Clinical Research</addr-line>, <institution>Schering-Plough Research Institute</institution>, <addr-line>Molenstraat 110, PO Box 20, Oss</addr-line>, <country>The Netherlands</country></aff><aff id="af4"><label>4</label><addr-line>Research Data and Quantitative Sciences</addr-line>, <institution>Schering-Plough Research Institute</institution>, <addr-line>Oss</addr-line>, <country>The Netherlands</country></aff><aff id="af5"><label>5</label><addr-line>Department of Reproductive Medicine and Gynecology</addr-line>, <institution>University Medical Center</institution>, <addr-line>Utrecht</addr-line>, <country>The Netherlands</country></aff><author-notes><corresp id="cor1"><label>6</label>Correspondence address. E-mail: <email>b.mannaerts@spcorp.com</email></corresp><fn id="FN1"><label>†</label><p>ENGAGE investigators: <italic>Belgium</italic>: Devroey, UZ Brusssel, Center for Reproductive Medicine, Brussels; Dhont, University Hospital Ghent, Department of Gynecology. <italic>Canada</italic>: Leader, The Ottawa Fertility Center, Ottawa, Ontario. <italic>Czech Republic</italic>: Mardesic, Sanatorium Pronatal, Prague; Mrázek, ISCARE IVF a.s., Prague. <italic>Denmark</italic>: Blaabjerg, Herlev Hospital, Fertility Clinic, Herlev. <italic>Finland</italic>: Tapanainen, Naistentautien klinikka, Oulun yliopistollinen sairaala (OYS), Oulu; Varila, Väestöliitto, Tampereen klinikka, Tampere. <italic>France</italic>: Barrière, Hôpital de la mère et de l'enfant, Nantes; Hedon, Hôpital Arnaud de Villeneuve, Montpellier. <italic>The Netherlands</italic>: Fauser and Sterrenburg, University Medical Center, Department of Reproductive Medicine & Gynecology, Utrecht. <italic>Norway</italic>: Kahn, Sykehuset Telemark HF, Skien; Von Düring, St. Olavs Hospital HF, Trondheim. <italic>Spain</italic>: Bajo Arenas, Ginefiv, Madrid; Barri, Institut Universitari Dexeus, Barcelona; Fernández-Sánchez, IVI Sevilla, Sevilla. <italic>Sweden</italic>: Bergh, Kvinnokliniken, Sahlgrenska Universitetssjukhuset, Göteborg; Hillensjö, Fertilitetscentrum, Carlanderska Sjukhuset, Göteborg. <italic>United Kingdom</italic>: Balen, Assisted Conception Unit, Leeds General Infirmary; Ledger, Assisted Conception Unit, Jessop Wing, The Halllamshire Hospital, Sheffield; Matthews, Bourn Hall Clinic, Cambridge. <italic>United States of America</italic>: Abuzeid, IVF Michigan, Rochester Hills (MI), Alper, Boston IVF, Waltham (MA); Boostanfar, Huntington Reproductive Center, Westlake Village (CA); Doody, Center for Assisted Reproduction, Bedford (TX); Frattarelli, Reproductive Medicine Associates of New Jersey, Morristown (NJ); Grunfeld, Reproductive Medicine Associates of New York, New York (NY); Karande, Karande and Associates SC, Hoffman Estates (IL); Kort, Reproductive Biology Associates, Atlanta (GA); Levy, Shady Grove Fertility Reproductive Science Center, Rockville (MD); Lifchez, Fertility Centers of Illinois, Chicago (IL); Pang, Reproductive Science Center of Boston, Lexington (MA); Schoolcraft, Colorado Center for Reproductive Medicine, Englewood (CO); Yeko, The Reproductive Medicine Group, Tampa (FL).</p></fn></author-notes><pub-date pub-type="ppub"><month>12</month><year>2009</year></pub-date><pub-date pub-type="epub"><day>14</day><month>8</month><year>2009</year></pub-date><volume>24</volume><issue>12</issue><fpage>3063</fpage><lpage>3072</lpage><history><date date-type="received"><day>17</day><month>2</month><year>2009</year></date><date date-type="rev-recd"><day>14</day><month>7</month><year>2009</year></date><date date-type="accepted"><day>20</day><month>7</month><year>2009</year></date></history><copyright-statement>© The Author 2009. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.</copyright-statement><copyright-year>2009</copyright-year><license license-type="creative-commons" xlink:href="http://creativecommons.org/licenses/by-nc/2.0/uk/"><p>This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.5/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.</p></license><abstract><sec><title>BACKGROUND</title><p>Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation.</p></sec><sec><title>METHODS</title><p>In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 µg corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol.</p></sec><sec><title>RESULTS</title><p>The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9% for the corifollitropin alfa group and 38.1% for rFSH were achieved, with an estimated non-significant difference of 0.9% [95% confidence interval (CI): −3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulus–oocyte-complexes compared with rFSH [estimated difference 1.2 (95% CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7%, respectively <italic>P</italic> = 0.15).</p></sec><sec><title>CONCLUSION</title><p>Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.</p></sec></abstract><kwd-group><kwd>corifollitropin alfa</kwd><kwd>sustained follicle stimulant</kwd><kwd>FSH</kwd><kwd>ovarian stimulation</kwd><kwd>IVF</kwd></kwd-group></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol</title></titleInfo><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Devroey</namePart><affiliation>Center for Reproductive Medicine, UZ Brussel, Brussels, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Boostanfar</namePart><affiliation>Huntington Reproductive Center, Westlake Village, CA, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.P.</namePart><namePart type="family">Koper</namePart><affiliation>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.M.J.L.</namePart><namePart type="family">Mannaerts</namePart><affiliation>Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands</affiliation><affiliation>E-mail: b.mannaerts@spcorp.com</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.C.</namePart><namePart type="family">IJzerman-Boon</namePart><affiliation>Research Data and Quantitative Sciences, Schering-Plough Research Institute, Oss, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart>on behalf of the ENGAGE Investigators</namePart><namePart type="given">B.C.J.M.</namePart><namePart type="family">Fauser</namePart><affiliation>Department of Reproductive Medicine and Gynecology, University Medical Center, Utrecht, The Netherlands</affiliation><description>ENGAGE investigators: Belgium: Devroey, UZ Brusssel, Center for Reproductive Medicine, Brussels; Dhont, University Hospital Ghent, Department of Gynecology. Canada: Leader, The Ottawa Fertility Center, Ottawa, Ontario. Czech Republic: Mardesic, Sanatorium Pronatal, Prague; Mrzek, ISCARE IVF a.s., Prague. Denmark: Blaabjerg, Herlev Hospital, Fertility Clinic, Herlev. Finland: Tapanainen, Naistentautien klinikka, Oulun yliopistollinen sairaala (OYS), Oulu; Varila, Vestliitto, Tampereen klinikka, Tampere. France: Barrire, Hpital de la mre et de l'enfant, Nantes; Hedon, Hpital Arnaud de Villeneuve, Montpellier. The Netherlands: Fauser and Sterrenburg, University Medical Center, Department of Reproductive Medicine & Gynecology, Utrecht. Norway: Kahn, Sykehuset Telemark HF, Skien; Von Dring, St. Olavs Hospital HF, Trondheim. Spain: Bajo Arenas, Ginefiv, Madrid; Barri, Institut Universitari Dexeus, Barcelona; Fernndez-Snchez, IVI Sevilla, Sevilla. Sweden: Bergh, Kvinnokliniken, Sahlgrenska Universitetssjukhuset, Gteborg; Hillensj, Fertilitetscentrum, Carlanderska Sjukhuset, Gteborg. United Kingdom: Balen, Assisted Conception Unit, Leeds General Infirmary; Ledger, Assisted Conception Unit, Jessop Wing, The Halllamshire Hospital, Sheffield; Matthews, Bourn Hall Clinic, Cambridge. United States of America: Abuzeid, IVF Michigan, Rochester Hills (MI), Alper, Boston IVF, Waltham (MA); Boostanfar, Huntington Reproductive Center, Westlake Village (CA); Doody, Center for Assisted Reproduction, Bedford (TX); Frattarelli, Reproductive Medicine Associates of New Jersey, Morristown (NJ); Grunfeld, Reproductive Medicine Associates of New York, New York (NY); Karande, Karande and Associates SC, Hoffman Estates (IL); Kort, Reproductive Biology Associates, Atlanta (GA); Levy, Shady Grove Fertility Reproductive Science Center, Rockville (MD); Lifchez, Fertility Centers of Illinois, Chicago (IL); Pang, Reproductive Science Center of Boston, Lexington (MA); Schoolcraft, Colorado Center for Reproductive Medicine, Englewood (CO); Yeko, The Reproductive Medicine Group, Tampa (FL).</description><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><originInfo><publisher>Oxford University Press</publisher><dateIssued encoding="w3cdtf">2009-12</dateIssued><dateCreated encoding="w3cdtf">2009-08-14</dateCreated><copyrightDate encoding="w3cdtf">2009</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>BACKGROUND Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation. METHODS In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 g corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol. RESULTS The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9 for the corifollitropin alfa group and 38.1 for rFSH were achieved, with an estimated non-significant difference of 0.9 [95 confidence interval (CI): 3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulusoocyte-complexes compared with rFSH [estimated difference 1.2 (95 CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7, respectively P 0.15). CONCLUSION Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.</abstract><note type="footnotes">ENGAGE investigators: Belgium: Devroey, UZ Brusssel, Center for Reproductive Medicine, Brussels; Dhont, University Hospital Ghent, Department of Gynecology. Canada: Leader, The Ottawa Fertility Center, Ottawa, Ontario. Czech Republic: Mardesic, Sanatorium Pronatal, Prague; Mrzek, ISCARE IVF a.s., Prague. Denmark: Blaabjerg, Herlev Hospital, Fertility Clinic, Herlev. Finland: Tapanainen, Naistentautien klinikka, Oulun yliopistollinen sairaala (OYS), Oulu; Varila, Vestliitto, Tampereen klinikka, Tampere. France: Barrire, Hpital de la mre et de l'enfant, Nantes; Hedon, Hpital Arnaud de Villeneuve, Montpellier. The Netherlands: Fauser and Sterrenburg, University Medical Center, Department of Reproductive Medicine & Gynecology, Utrecht. Norway: Kahn, Sykehuset Telemark HF, Skien; Von Dring, St. Olavs Hospital HF, Trondheim. Spain: Bajo Arenas, Ginefiv, Madrid; Barri, Institut Universitari Dexeus, Barcelona; Fernndez-Snchez, IVI Sevilla, Sevilla. Sweden: Bergh, Kvinnokliniken, Sahlgrenska Universitetssjukhuset, Gteborg; Hillensj, Fertilitetscentrum, Carlanderska Sjukhuset, Gteborg. United Kingdom: Balen, Assisted Conception Unit, Leeds General Infirmary; Ledger, Assisted Conception Unit, Jessop Wing, The Halllamshire Hospital, Sheffield; Matthews, Bourn Hall Clinic, Cambridge. United States of America: Abuzeid, IVF Michigan, Rochester Hills (MI), Alper, Boston IVF, Waltham (MA); Boostanfar, Huntington Reproductive Center, Westlake Village (CA); Doody, Center for Assisted Reproduction, Bedford (TX); Frattarelli, Reproductive Medicine Associates of New Jersey, Morristown (NJ); Grunfeld, Reproductive Medicine Associates of New York, New York (NY); Karande, Karande and Associates SC, Hoffman Estates (IL); Kort, Reproductive Biology Associates, Atlanta (GA); Levy, Shady Grove Fertility Reproductive Science Center, Rockville (MD); Lifchez, Fertility Centers of Illinois, Chicago (IL); Pang, Reproductive Science Center of Boston, Lexington (MA); Schoolcraft, Colorado Center for Reproductive Medicine, Englewood (CO); Yeko, The Reproductive Medicine Group, Tampa (FL).</note><subject><genre>keywords</genre><topic>corifollitropin alfa</topic><topic>sustained follicle stimulant</topic><topic>FSH</topic><topic>ovarian stimulation</topic><topic>IVF</topic></subject><relatedItem type="host"><titleInfo><title>Human Reproduction</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0268-1161</identifier><identifier type="eISSN">1460-2350</identifier><identifier type="PublisherID">humrep</identifier><identifier type="PublisherID-hwp">humrep</identifier><part><date>2009</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><detail type="issue"><caption>no.</caption><number>12</number></detail><extent unit="pages"><start>3063</start><end>3072</end></extent></part></relatedItem><identifier type="istex">82375B78B6F4D81A02A163136FCE4CAA43E4ECB0</identifier><identifier type="DOI">10.1093/humrep/dep291</identifier><identifier type="ArticleID">dep291</identifier><accessCondition type="use and reproduction" contentType="copyright">The Author 2009. 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