Skip Navigation


Hum. Reprod. Advance Access originally published online on April 20, 2007
Human Reproduction 2007 22(7):1816-1823; doi:10.1093/humrep/dem075
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF ) Freely available
Right arrow All Versions of this Article:
22/7/1816    most recent
dem075v1
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 ISI Web of Science
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 arrow Search for citing articles in:
ISI Web of Science (1)
Right arrowRequest Permissions
Google Scholar
Right arrow Articles by Balen, A.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Balen, A.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© The Author 2007. 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

Highly purified FSH is as efficacious as recombinant FSH for ovulation induction in women with WHO Group II anovulatory infertility: a randomized controlled non-inferiority trial

Adam Balen1,5, Peter Platteau2, Anders Nyboe Andersen3, Paul Devroey2, Lisbeth Helmgaard4, Joan-Carles Arce for the Bravelle Ovulation Induction (BOI) Study Group4

1 Leeds General Infirmary, Department of Obstetrics and Gynaecology, Clarendon Wing, Leeds General Infirmary, Belmont Grove, Leeds LS2 9NS, UK 2 Center for Reproductive Medicine of the Vrije Universiteit Brussel (VUB), Brussels, Belgium 3 Rigshospitalet, Fertility Clinic, Copenhagen, Denmark 4 Ferring Pharmaceuticals A/S, Obstetrics and Gynaecology, Clinical Research and Development, Copenhagen, Denmark

5 Correspondence address. Tel: +44-113-392-2728; Fax: +44-113-392-2446; E-mail: adam.balen{at}leedsth.nhs.uk

BACKGROUND: The objective of this study was to demonstrate non-inferiority of a highly purified urinary follicle stimulating hormone (HP-FSH) preparation compared with a recombinant (rFSH) preparation with respect to ovulation rate (primary end-point).

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-FSH (n = 73) or rFSH (n = 78) using a low-dose step-up protocol. The non-inferiority limit was prespecified at –20%.

RESULTS: The ovulation rate was 85.2% (51/62) with HP-FSH and 90.9% (60/66) with rFSH (per-protocol population), and non-inferiority was demonstrated [95% confidence interval: –16.9; 5.6]. No differences were noted between groups in number of follicles ≥12 mm, ≥15 mm or ≥ 18 mm, mono-follicular development, pregnancy rates, endometrial thickness, number of ovarian stimulation syndrome cases or frequency of injection site reactions/pain. The singleton live birth rate was 15% in both groups (11/73 with HP-FSH and 12/78 with rFSH).

CONCLUSIONS: This urinary HP-FSH preparation is non-inferior compared with a rFSH preparation with respect to ovulation rate in anovulatory WHO Group II women failing to ovulate or conceive on clomiphene citrate.

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

Submitted on September 29, 2006; resubmitted on February 15, 2007; accepted on February 28, 2007.


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


This article has been cited by other articles:


Home page
 Hum ReprodHome page
A. Nyboe Andersen, A. Balen, P. Platteau, P. Devroey, L. Helmgaard, J.-C. Arce, and for the Bravelle Ovulation Induction (BOI) Study G
Predicting the FSH threshold dose in women with WHO Group II anovulatory infertility failing to ovulate or conceive on clomiphene citrate
Hum. Reprod., June 1, 2008; 23(6): 1424 - 1430.
[Abstract] [Full Text] [PDF]


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.