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Hum. Reprod. Advance Access originally published online on March 29, 2006
Human Reproduction 2006 21(7):1798-1804; doi:10.1093/humrep/del085
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© The Author 2006. 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 The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed; the Journal and Oxford University Press are attributed as the original place of publication with the correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org

Similar ovulation rates, but different follicular development with highly purified menotrophin compared with recombinant FSH in WHO Group II anovulatory infertility: a randomized controlled study

Peter Platteau 1 , 5 , Anders Nyboe Andersen 2 , Adam Balen 3 , Paul Devroey 1 , Per Sørensen 4 , Lisbeth Helmgaard 4 , Joan-Carles Arce 4 for the Menopur Ovulation Induction (MOI) Study Group

1 Center for Reproductive Medicine of the Vrije Universiteit Brussel, Brussels, Belgium 2 Rigshospitalet, Fertility Clinic, Copenhagen, Denmark 3 Leeds General Infirmary, Department of Obstetrics & Gynaecology, Leeds, UK and 4 Ferring Pharmaceuticals A/S, Obstetrics & Gynaecology, Clinical Research & Development, Copenhagen, Denmark

5 To whom correspondence should be addressed: Center for Reproductive Medicine of the Vrije Universiteit Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium. E-mail: peter.platteau{at}az.vub.ac.be

BACKGROUND: The contribution of the LH activity in menotrophin preparations for ovulation induction has been investigated in small trials conducted versus FSH preparations. The objective of this study was to demonstrate non-inferiority of highly purified urinary menotrophin (HP-HMG) versus recombinant FSH (rFSH) with respect to the primary outcome measure, ovulation rate. METHODS: This was a randomized, open-label, assessor-blind, multinational study. Women with anovulatory infertility WHO Group II and resistant to clomiphene citrate were randomized (computer-generated list) to stimulation with HP-HMG (n = 91) or rFSH (n = 93) using a low-dose step-up protocol. RESULTS: The ovulation rate was 85.7% with HP-HMG and 85.5% with rFSH (per-protocol population), and non-inferiority was demonstrated. Significantly fewer intermediate-sized follicles were observed in the HP-HMG group (P < 0.05). The singleton live birth rate was comparable between the two groups. The frequency of ovarian hyperstimulation syndrome and/or cancellation due to excessive response was 2.2% with HP-HMG and 9.8% with rFSH (P = 0.058). CONCLUSIONS: Stimulation with HP-HMG is associated with ovulation rates at least as good as a rFSH in anovulatory WHO Group II women. LH activity modifies follicular development so that fewer intermediate-sized follicles develop. This could have a positive impact on the safety of ovulation induction protocols.

Key words: anovulation/highly purified menotrophin/ovulation induction/polycystic ovary syndrome/recombinant FSH


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