Skip Navigation



Hum. Reprod. Advance Access published online on August 6, 2008
Human Reproduction, doi:10.1093/humrep/den288
This Article
Right arrow Full Text
Right arrow Full Text (PDF )
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
PubMed
Right arrow PubMed Citation
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© The Author 2008. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

A randomized dose–response trial of a single injection of corifollitropin alfa to sustain multifollicular growth during controlled ovarian stimulation{dagger}

The Corifollitropin Alfa Dose-finding Study Group1

1 Correspondence address. Norbert Koper, Global Clinical Development Department, NV Organon, a part of Schering-Plough Corporation, Molenstraat 110, PO Box 20, 5340 BH Oss, The Netherlands. E-mail: norbert.koper{at}spcorp.com

BACKGROUND: This study primarily investigated the dose–response relationship of corifollitropin alfa to initiate multifollicular development for the first 7 days of controlled ovarian stimulation (COS).

METHODS: Women aged 20–39 years undergoing COS for in vitro fertilization or intracytoplasmic sperm injection were randomized to a single dose of corifollitropin alfa 60, 120 or 180 µg, or daily injections of 150 IU recombinant follicle-stimulating hormone (rFSH). Patients treated with corifollitropin alfa started fixed daily treatment with 150 IU rFSH on stimulation Day 8. Patients received a GnRH antagonist (ganirelix 0.25 mg/day) from stimulation Day 5 until the day of human chorionic gonadotrophin.

RESULTS: Pharmacokinetics of corifollitropin alfa were dose-proportional. The main reason for not having embryo transfer was insufficient ovarian response in 30.8, 2.6, 3.8 and 7.4% of patients in the corifollitropin alfa 60, 120, 180 µg and rFSH groups, respectively. On Day 8, the mean (standard deviation) number of follicles ≥11 mm was 6.8 (4.4), 10.1 (6.1) and 12.8 (7.5), respectively. The number of cumulus–oocyte complexes retrieved showed a clear dose–response relationship (P < 0.0001), being 5.2 (5.5), 10.3 (6.3) and 12.5 (8.0) in the three dose groups, respectively.

CONCLUSIONS: A single injection of corifollitropin alfa induces dose-related increase in multifollicular development and in the number of retrieved oocytes. The optimal dose for a 1-week interval is higher than 60 µg and lower than 180 µg and will be selected based on modelling and simulation taking into account insufficient stimulation as well as overstimulation. Clinical Trials gov: NCT00598208 [ClinicalTrials.gov] .

Key words: corifollitropin alfa/rFSH/controlled ovarian stimulation/IVF/sustained follicle stimulant

{dagger} Results from this study have been presented at the 22nd Annual Meeting of the European Society for Human Reproduction & Embryology, Prague, Czech Republic, 18–21 June 2006.

Submitted on November 26, 2007; resubmitted on June 23, 2008; accepted on June 30, 2008.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?




Disclaimer:
Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.