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Hum. Reprod. Advance Access originally published online on August 27, 2004
Human Reproduction 2004 19(10):2206-2215; doi:10.1093/humrep/deh357
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Human Reproduction vol. 19 no. 10 © European Society of Human Reproduction and Embryology 2004; all rights reserved

Dose-finding study of daily gonadotropin-releasing hormone (GnRH) antagonist for the prevention of premature luteinizing hormone surges in IVF/ICSI patients: antide and hormone levels

Judith A.F. Huirne, Andre C.D. van Loenen, Roel Schats, Joseph McDonnell, Peter G.A. Hompes, Joop Schoemaker, Roy Homburg and Cornelis B. Lambalk1

Division of Reproductive Medicine, Department of Obstetrics and Gynaecology, Vrije Universiteit medical centre (VUmc), Amsterdam, The Netherlands

1 To whom correspondence should be addressed at: Department of Obstetrics and Gynaecology, VUmc, PO Box 7075, 1007 MB Amsterdam, The Netherlands. Email: cb.lambalk{at}vumc.nl

BACKGROUND: The aim of this study was to define the minimal effective dose of antide (Iturelix) to prevent premature luteinizing hormone (LH) surges in in vitro fertilization (IVF) patients. METHODS: In a prospective, single centre study, 144 IVF/ICSI patients were stimulated with r-hFSH from cycle day 2 and from cycle day 6 onwards, cotreated with daily 2 mg/2 ml (n=30), 1 mg/ml (n=30), 0.5 mg/ml (n=31), 0.5 mg/0.5 ml (n=23) and 0.25 mg/ml (n=30) GnRH antagonist (antide). Serum samples were taken three times daily during antide administration to assess antide and hormone levels. The minimal effective dose was defined as the lowest dose group with <2 LH surges (LH >12.4 IU/l and progesterone >2 ng/ml). RESULTS: Serum antide levels, mean LH and E2 levels per day and their area under the curves were dose-related to antide. The bioavailability of antide almost doubled after dilution in larger volumes. Pre-injection LH levels gradually increased during GnRH antagonist treatment. LH surges occurred in the lowest dose groups 0.5 mg/ml (3.2%), 0.5 mg/0.5 ml (6.7%) and 0.25 mg/ml (13.3%). Hence, 0.5 mg/ml is considered to be the minimal effective dose. Antide was overall well tolerated and safe. CONCLUSIONS: 0.5 mg/ml antide is the minimal effective dose to prevent an untimely LH surge in IVF patients stimulated with r-hFSH.

Key words: antide/dose-finding/GnRH antagonist/IVF/LH


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