Comparative incidence of ovarian hyperstimulation syndrome following ovarian stimulation with corifollitropin alfa or recombinant FSH

Basil C. Tarlatzis; Georg Griesinger; Arthur Leader; Luk Rombauts; Pieta C. Ijzerman-Boon; Bernadette M.J.L. Mannaerts

doi:10.1016/j.rbmo.2012.01.005

Comparative incidence of ovarian hyperstimulation syndrome following ovarian stimulation with corifollitropin alfa or recombinant FSH

Basil C. Tarlatzis, Georg Griesinger, Arthur Leader, Luk Rombauts, Pieta C. Ijzerman-Boon, Bernadette M.J.L. Mannaerts^*

^*Korrespondierende/r Autor/-in für diese Arbeit

Klinik für Frauenheilkunde und Geburtshilfe

28 Zitate (Scopus)

Abstract

Corifollitropin alfa is a novel recombinant gonadotrophin with sustained follicle-stimulating activity. A single injection can replace seven daily injections of recombinant follicle-stimulating hormone (rFSH) during the first week of ovarian stimulation. All cases of ovarian hyperstimulation syndrome (OHSS) with corifollitropin alfa intervention in a gonadotrophin-releasing hormone antagonist protocol have been assessed in three large trials: Engage, Ensure and Trust. Overall, 1705 patients received corifollitropin alfa and 5.6% experienced mild, moderate or severe OHSS. In the randomized controlled trials, Engage and Ensure, the pooled incidence of OHSS with corifollitropin alfa was 6.9% (71/1023 patients) compared with 6.0% (53/880 patients) in the rFSH group. Adjusted for trial, the odds ratio for OHSS was 1.18 (95% CI 0.81-1.71) indicating that the risk of OHSS for corifollitropin alfa was similar to that for rFSH. The incidence of mild, moderate and severe OHSS was 3.0%, 2.2% and 1.8%, respectively, with corifollitropin alfa, with 1.9% requiring hospitalization, and 3.5%, 1.3% and 1.3%, respectively, in the rFSH arms, with 0.9% requiring hospitalization. Despite a higher ovarian response with corifollitropin alfa compared with rFSH for the first 7 days of ovarian stimulation, the incidence of OHSS was similar. Corifollitropin alfa is a new agent used in ovarian stimulation treatment for IVF fertilization. One injection of corifollitropin alfa can replace seven injections of recombinant FSH (rFSH). In three studies of corifollitropin alfa treatment, we assessed all cases of ovarian hyperstimulation syndrome (OHSS), a potentially serious complication of ovarian stimulation treatment. Overall, 5.6% of the patients (95/1701) experienced OHSS. Two of the trials compared corifollitropin alfa versus rFSH. Because OHSS is relatively rare, we pooled the results of these trials to give a more reliable estimate of the incidence of OHSS. In the pooled analysis, 6.9% (71/1023) of patients receiving corifollitropin alfa had signs or symptoms of OHSS, compared with 6.0% in the rFSH group (53/880). The risk of OHSS with corifollitropin alfa treatment was similar to the risk of OHSS in patients who received rFSH: the incidence of mild, moderate and severe OHSS was 3.0%, 2.2% and 1.8%, respectively, in patients in the corifollitropin alfa treatment groups, with 1.9% requiring hospitalisation, and 3.5%, 1.3% and 1.3%, respectively, in patients in the rFSH treatment groups, with 0.9% requiring hospitalization. Although the ovaries respond more to corifollitropin alfa than to rFSH for the first 7 days of ovarian stimulation, neither treatment regimen was significantly more likely to cause OHSS.

Originalsprache	Englisch
Zeitschrift	Reproductive BioMedicine Online
Jahrgang	24
Ausgabenummer	4
Seiten (von - bis)	410-419
Seitenumfang	10
ISSN	1472-6483
DOIs	https://doi.org/10.1016/j.rbmo.2012.01.005
Publikationsstatus	Veröffentlicht - 01.04.2012

Fördermittel

Financial support for this study was provided by Merck Sharp & Dohme Corp. , a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ. Medical writing and editorial assistance was provided by P Milner, PhD, of PAREXEL. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ. Appendix Engage Investigators: Belgium: Devroey, UZ Brussel, Centre for Reproductive Medicine, Brussels; Dhont, University Hospital Ghent, Department of Gynecology. Canada : Leader, The Ottawa Fertility Centre, Ottawa, Ontario. Czech Republic : Mardešić, Sanatorium Pronatal, Prague; Mrázek, ISCARE IVF a.s., Prague. Denmark : Blaabjerg, Herlev Hospital, Fertility Clinic, Herlev. Finland : Tapanainen, Naistentautien klinikka, Oulun yliopistollinen sairaala (OYS), Oulu; Varila, Väestöliitto, Tampereen klinikka, Tampere. France : Barrière, Hôpital de la mère et de l’enfant, Nantes; Hedon, Hôpital Arnaud de Villeneuve, Montpellier. The Netherlands : Fauser and Sterrenburg, University Medical Centre, Department of Reproductive Medicine and Gynecology, Utrecht. Norway : Kahn, Sykehuset Telemark HF, Skien; Von Düring, St. Olavs Hospital HF, Trondheim. Spain : Bajo Arenas, Ginefiv, Madrid; Barri, Institut Universitari Dexeus, Barcelona; Fernández-Sánchez, IVI Sevilla, Sevilla. Sweden : Bergh, Kvinnokliniken, Sahlgrenska Universitetssjukhuset, Göteborg; Hillensjö, Fertilitetscentrum, Carlanderska Sjukhuset, Göteborg. United Kingdom : Balen, Assisted Conception Unit, Leeds General Infirmary; Ledger, Assisted Conception Unit, Jessop Wing, The Hallamshire Hospital, Sheffield; Matthews, Bourn Hall Clinic, Cambridge. United States of America : Abuzeid, IVF Michigan, Rochester Hills (MI), Alper, Boston IVF, Waltham (MA); Boostanfar, untington Reproductive Centre, Westlake Village (CA); Doody, Centre 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 Centre, Rockville (MD); Lifchez, Fertility Centres of Illinois, Chicago (IL); Pang, Reproductive Science Centre of Boston, Lexington (MA); Schoolcraft, Colorado Centre for Reproductive Medicine, Englewood (CO); Yeko, The Reproductive Medicine Group, Tampa (FL). Ensure Investigators: Austria : Obruca, Kinderwunschzentrum Privatspital Goldenes Kreuz, Vienna; Schenk, Kinderwunsch Institut Schenk GmbH, Dobl; Tews, Landes-Frauen-Und Kinderklinik Linz, Linz. Czech Republic: Mardešić, Sanatorium Pronatal, Prague; Mrázek, ISCARE I.V.F. a.s, Prague. Denmark : Meinertz, The Fertility Clinic, Hvidovre Hospital, Hvidovre. France : Hedon, Hôpital Arnaud de Villeneuve, Montpellier; Barrière Hôpital de la mère et de l’enfant, Nantes. South Korea : Kim, Asan Medical Centre, Seoul; Koong, Kwandong University, Cheil General Hospital, Seoul; Yoon, CHA General Hospital, Seoul. Poland : Koziol, Przychodnia Lekarska ‘Novum’, Warsaw; Kuczynski, Centrum Leczenia Nieplodnosci Malzenskiej ‘Kriobank’, Bialystok. Spain : Bernabeu, Instituto Bernabeu, Alicante; Balda, Hospital Universitario ‘12 de Octubre’, Madrid. Sweden : Bergh, Kvinnokliniken, Sahlgrenska Universitetssjukhuset, Göteborg; Hillensjö, Fertilitetscentrum Carlanderska Sjukhuset, Göteborg. Taiwan: Huang, Chang Gung Memorial Hospital Linkou, Tao Yuan; Yang, National Taiwan University Hospital, Taipei. Trust Investigators: Argentina : Papier, CEGyR Buenos Aires; Vilela, IFER Buenos Aires; Blaquier, FERTILAB Riobamba, Buenos Aires; Ruhlmann, San Isidro Medicina, San Isidro; Botti, PROAR, Rosario; Pasqualini, Halitus, Buenos Aires. Australia : Rombauts, Monash IVF, Clayton, Victoria; Hale, Melbourne IVF, East Melbourne, Victoria; Watkins, Tasmania IVF, Hobart; Norman, Repromed, Dulwich, SA and University of Adelaide; Illingworth, IVF Australia, Westmead, NSW. Brazil : Petracco, Hospital de Sao Lucas, Porto Alegre-RS; Ferriani, Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto, Ribeirao Preto; Chile : Devoto, Instituto de Investigacion Materno Infantil (IDIMI), Santiago; Zegers-Hochschild and Camus, Clinica las Condes, Santiago; Germany : Schultze-Mosgau, Universitätklinikum Lübeck, Lübeck; Dieterle, Kinderwunschcentrum Dortmund, Dortmund; Fiedler, Kinderwunsch Centrum München, München. Denmark : Nyboe Andersen, Rigshospitalet, København Ø. France : Salle, Groupement Hospitalier Est Hopital Femme Mere Infant PMA, Bron; Hazout, Clinique de la Muette, Paris. Hungary : Konc, St Janos Hospital and Outpatient Institute, Budapest. Italy : La Sala, Arcispedale S. Maria Nuova, Reggio Emilia; De Placido, Azienda Universitaria Policlinico Federico II, Napoli. Netherlands : Laven, Erasmus Medisch Centrum, Rotterdam; Lambalk, Academisch Ziekenhuis Vrije Universteit Amsterdam, Amsterdam; Jansen, Reinier de Graaf Groep, Voorburg; Cohlen, Isala Klinieken (locatie Sophia), Zwolle. Norway : Tanbo, Rikshospitalet HF, Oslo. Sweden : Wramsby, IVF Kliniken St. Görans, Stockholm.

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10.1016/j.rbmo.2012.01.005

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@article{8b3d0eb98f184fe5a126620a50835a7c,

title = "Comparative incidence of ovarian hyperstimulation syndrome following ovarian stimulation with corifollitropin alfa or recombinant FSH",

abstract = "Corifollitropin alfa is a novel recombinant gonadotrophin with sustained follicle-stimulating activity. A single injection can replace seven daily injections of recombinant follicle-stimulating hormone (rFSH) during the first week of ovarian stimulation. All cases of ovarian hyperstimulation syndrome (OHSS) with corifollitropin alfa intervention in a gonadotrophin-releasing hormone antagonist protocol have been assessed in three large trials: Engage, Ensure and Trust. Overall, 1705 patients received corifollitropin alfa and 5.6\% experienced mild, moderate or severe OHSS. In the randomized controlled trials, Engage and Ensure, the pooled incidence of OHSS with corifollitropin alfa was 6.9\% (71/1023 patients) compared with 6.0\% (53/880 patients) in the rFSH group. Adjusted for trial, the odds ratio for OHSS was 1.18 (95\% CI 0.81-1.71) indicating that the risk of OHSS for corifollitropin alfa was similar to that for rFSH. The incidence of mild, moderate and severe OHSS was 3.0\%, 2.2\% and 1.8\%, respectively, with corifollitropin alfa, with 1.9\% requiring hospitalization, and 3.5\%, 1.3\% and 1.3\%, respectively, in the rFSH arms, with 0.9\% requiring hospitalization. Despite a higher ovarian response with corifollitropin alfa compared with rFSH for the first 7 days of ovarian stimulation, the incidence of OHSS was similar. Corifollitropin alfa is a new agent used in ovarian stimulation treatment for IVF fertilization. One injection of corifollitropin alfa can replace seven injections of recombinant FSH (rFSH). In three studies of corifollitropin alfa treatment, we assessed all cases of ovarian hyperstimulation syndrome (OHSS), a potentially serious complication of ovarian stimulation treatment. Overall, 5.6\% of the patients (95/1701) experienced OHSS. Two of the trials compared corifollitropin alfa versus rFSH. Because OHSS is relatively rare, we pooled the results of these trials to give a more reliable estimate of the incidence of OHSS. In the pooled analysis, 6.9\% (71/1023) of patients receiving corifollitropin alfa had signs or symptoms of OHSS, compared with 6.0\% in the rFSH group (53/880). The risk of OHSS with corifollitropin alfa treatment was similar to the risk of OHSS in patients who received rFSH: the incidence of mild, moderate and severe OHSS was 3.0\%, 2.2\% and 1.8\%, respectively, in patients in the corifollitropin alfa treatment groups, with 1.9\% requiring hospitalisation, and 3.5\%, 1.3\% and 1.3\%, respectively, in patients in the rFSH treatment groups, with 0.9\% requiring hospitalization. Although the ovaries respond more to corifollitropin alfa than to rFSH for the first 7 days of ovarian stimulation, neither treatment regimen was significantly more likely to cause OHSS.",

author = "Tarlatzis, \{Basil C.\} and Georg Griesinger and Arthur Leader and Luk Rombauts and Ijzerman-Boon, \{Pieta C.\} and Mannaerts, \{Bernadette M.J.L.\}",

year = "2012",

month = apr,

day = "1",

doi = "10.1016/j.rbmo.2012.01.005",

language = "English",

volume = "24",

pages = "410--419",

journal = "Reproductive BioMedicine Online",

issn = "1472-6483",

publisher = "Elsevier Ltd",

number = "4",

}

Comparative incidence of ovarian hyperstimulation syndrome following ovarian stimulation with corifollitropin alfa or recombinant FSH. / Tarlatzis, Basil C.; Griesinger, Georg; Leader, Arthur et al.
in: Reproductive BioMedicine Online, Jahrgang 24, Nr. 4, 01.04.2012, S. 410-419.

Publikation: Beiträge in Fachzeitschriften › Zeitschriftenaufsätze › Forschung › Begutachtung

TY - JOUR

T1 - Comparative incidence of ovarian hyperstimulation syndrome following ovarian stimulation with corifollitropin alfa or recombinant FSH

AU - Tarlatzis, Basil C.

AU - Griesinger, Georg

AU - Leader, Arthur

AU - Rombauts, Luk

AU - Ijzerman-Boon, Pieta C.

AU - Mannaerts, Bernadette M.J.L.

PY - 2012/4/1

Y1 - 2012/4/1

N2 - Corifollitropin alfa is a novel recombinant gonadotrophin with sustained follicle-stimulating activity. A single injection can replace seven daily injections of recombinant follicle-stimulating hormone (rFSH) during the first week of ovarian stimulation. All cases of ovarian hyperstimulation syndrome (OHSS) with corifollitropin alfa intervention in a gonadotrophin-releasing hormone antagonist protocol have been assessed in three large trials: Engage, Ensure and Trust. Overall, 1705 patients received corifollitropin alfa and 5.6% experienced mild, moderate or severe OHSS. In the randomized controlled trials, Engage and Ensure, the pooled incidence of OHSS with corifollitropin alfa was 6.9% (71/1023 patients) compared with 6.0% (53/880 patients) in the rFSH group. Adjusted for trial, the odds ratio for OHSS was 1.18 (95% CI 0.81-1.71) indicating that the risk of OHSS for corifollitropin alfa was similar to that for rFSH. The incidence of mild, moderate and severe OHSS was 3.0%, 2.2% and 1.8%, respectively, with corifollitropin alfa, with 1.9% requiring hospitalization, and 3.5%, 1.3% and 1.3%, respectively, in the rFSH arms, with 0.9% requiring hospitalization. Despite a higher ovarian response with corifollitropin alfa compared with rFSH for the first 7 days of ovarian stimulation, the incidence of OHSS was similar. Corifollitropin alfa is a new agent used in ovarian stimulation treatment for IVF fertilization. One injection of corifollitropin alfa can replace seven injections of recombinant FSH (rFSH). In three studies of corifollitropin alfa treatment, we assessed all cases of ovarian hyperstimulation syndrome (OHSS), a potentially serious complication of ovarian stimulation treatment. Overall, 5.6% of the patients (95/1701) experienced OHSS. Two of the trials compared corifollitropin alfa versus rFSH. Because OHSS is relatively rare, we pooled the results of these trials to give a more reliable estimate of the incidence of OHSS. In the pooled analysis, 6.9% (71/1023) of patients receiving corifollitropin alfa had signs or symptoms of OHSS, compared with 6.0% in the rFSH group (53/880). The risk of OHSS with corifollitropin alfa treatment was similar to the risk of OHSS in patients who received rFSH: the incidence of mild, moderate and severe OHSS was 3.0%, 2.2% and 1.8%, respectively, in patients in the corifollitropin alfa treatment groups, with 1.9% requiring hospitalisation, and 3.5%, 1.3% and 1.3%, respectively, in patients in the rFSH treatment groups, with 0.9% requiring hospitalization. Although the ovaries respond more to corifollitropin alfa than to rFSH for the first 7 days of ovarian stimulation, neither treatment regimen was significantly more likely to cause OHSS.

AB - Corifollitropin alfa is a novel recombinant gonadotrophin with sustained follicle-stimulating activity. A single injection can replace seven daily injections of recombinant follicle-stimulating hormone (rFSH) during the first week of ovarian stimulation. All cases of ovarian hyperstimulation syndrome (OHSS) with corifollitropin alfa intervention in a gonadotrophin-releasing hormone antagonist protocol have been assessed in three large trials: Engage, Ensure and Trust. Overall, 1705 patients received corifollitropin alfa and 5.6% experienced mild, moderate or severe OHSS. In the randomized controlled trials, Engage and Ensure, the pooled incidence of OHSS with corifollitropin alfa was 6.9% (71/1023 patients) compared with 6.0% (53/880 patients) in the rFSH group. Adjusted for trial, the odds ratio for OHSS was 1.18 (95% CI 0.81-1.71) indicating that the risk of OHSS for corifollitropin alfa was similar to that for rFSH. The incidence of mild, moderate and severe OHSS was 3.0%, 2.2% and 1.8%, respectively, with corifollitropin alfa, with 1.9% requiring hospitalization, and 3.5%, 1.3% and 1.3%, respectively, in the rFSH arms, with 0.9% requiring hospitalization. Despite a higher ovarian response with corifollitropin alfa compared with rFSH for the first 7 days of ovarian stimulation, the incidence of OHSS was similar. Corifollitropin alfa is a new agent used in ovarian stimulation treatment for IVF fertilization. One injection of corifollitropin alfa can replace seven injections of recombinant FSH (rFSH). In three studies of corifollitropin alfa treatment, we assessed all cases of ovarian hyperstimulation syndrome (OHSS), a potentially serious complication of ovarian stimulation treatment. Overall, 5.6% of the patients (95/1701) experienced OHSS. Two of the trials compared corifollitropin alfa versus rFSH. Because OHSS is relatively rare, we pooled the results of these trials to give a more reliable estimate of the incidence of OHSS. In the pooled analysis, 6.9% (71/1023) of patients receiving corifollitropin alfa had signs or symptoms of OHSS, compared with 6.0% in the rFSH group (53/880). The risk of OHSS with corifollitropin alfa treatment was similar to the risk of OHSS in patients who received rFSH: the incidence of mild, moderate and severe OHSS was 3.0%, 2.2% and 1.8%, respectively, in patients in the corifollitropin alfa treatment groups, with 1.9% requiring hospitalisation, and 3.5%, 1.3% and 1.3%, respectively, in patients in the rFSH treatment groups, with 0.9% requiring hospitalization. Although the ovaries respond more to corifollitropin alfa than to rFSH for the first 7 days of ovarian stimulation, neither treatment regimen was significantly more likely to cause OHSS.

UR - https://www.scopus.com/pages/publications/84859430618

U2 - 10.1016/j.rbmo.2012.01.005

DO - 10.1016/j.rbmo.2012.01.005

M3 - Journal articles

C2 - 22386594

AN - SCOPUS:84859430618

SN - 1472-6483

VL - 24

SP - 410

EP - 419

JO - Reproductive BioMedicine Online

JF - Reproductive BioMedicine Online

IS - 4

ER -

Comparative incidence of ovarian hyperstimulation syndrome following ovarian stimulation with corifollitropin alfa or recombinant FSH

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