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Hum. Reprod. Advance Access published online on July 27, 2006
Human Reproduction, doi:10.1093/humrep/del284
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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
Received April 26, 2006
Revised June 8, 2006
Accepted June 23, 2006

Article

Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial

Anders Nyboe Andersen 1 *, Paul Devroey 2, and Joan-Carles Arce 3, for the MERITM Group *

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

* To whom correspondence should be addressed.
Anders Nyboe Andersen, E-mail: anders.nyboe.andersen{at}rh.hosp.dk


  Abstract

BACKGROUND: LH activity may influence treatment response and outcome in IVF cycles. METHODS: A randomized, assessor-blind, multinational trial compared ongoing pregnancy rates (primary end-point) in 731 women undergoing IVF after stimulation with highly purified menotrophin (HP-hMG) (n = 363) or recombinant FSH (rFSH) (n = 368) following a long GnRH agonist protocol. Patients received identical pre- and post-randomization interventions. One or two embryos were transferred on day 3. RESULTS: More oocytes were retrieved (P < 0.001) after rFSH treatment (11.8) compared with HP-hMG treatment (10.0), but a higher proportion developed into top-quality embryos (P = 0.044) with HP-hMG (11.3%) than with rFSH (9.0%). At the end of stimulation, lower estradiol (E2) (P = 0.031) and higher progesterone (P < 0.001) levels were found with rFSH, even after adjusting for follicular response. The distribution of hypo-, iso- and hyper-echogenic endometrium showed a significant (P = 0.023) shift towards the hyperechogenic pattern after rFSH treatment. The ongoing pregnancy rate per cycle was 27% with HP-hMG and 22% with rFSH [odds ratio (95% confidence interval): 1.25 (0.89-1.75)]. CONCLUSION: Superiority of HP-hMG over rFSH in ongoing pregnancy rate could not be concluded from this study, but non-inferiority was established. Pharmacodynamic differences in follicular development, oocyte/embryo quality, endocrine response and endometrial echogenicity exist between HP-hMG and rFSH preparations, which may be relevant for treatment outcome.

Keywords: embryo quality/highly purified menotrophin/IVF/pregnancy/recombinant FSH.
*Menotrophin versus Recombinant FSH in vitro Fertilisation Trial
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