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Hum. Reprod. Advance Access published online on December 23, 2004

Human Reproduction, doi:10.1093/humrep/deh682
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Human Reproduction © European Society of Human Reproduction and Embryology 2004; all rights reserved
Received March 4, 2004
Revised October 14, 2004
Accepted November 9, 2004

Article

Does the addition of recombinant LH in WHO group II anovulatory women over-responding to FSH treatment reduce the number of developing follicles? A dose-finding study

J.N. Hugues 1*, J. Soussis 2, I. Calderon 3, J. Balasch 4, R.A. Anderson 5, A. Romeu 6, and on behalf of the Recombinant LH Study Group *

1 Center of Reproductive Medicine, Hôpital Jean Verdier, Bondy, France
2 IVF & Genetics, Athens, Greece
3 Lin Professional Clinic, Haifa, Israel
4 Hospital Clinic de Barcelona, Barcelona, Spain
5 Edinburgh Royal Infirmary, Edinburgh, UK
6 Hospital Universitario La Fe, Valencia, Spain

* To whom correspondence should be addressed.
J.N. Hugues, E-mail: jean-noel.hugues{at}jvr.ap-hop-paris.fr


   Abstract

BACKGROUND: In anovulatory women undergoing ovulation induction, addition of recombinant human LH (rLH) to FSH treatment may promote the dominance of a leading follicle when administered in the late follicular phase. The objective of this study was to find the optimal dose of rLH that can maintain the growth of a dominant follicle, whilst causing atresia of secondary follicles. METHODS: Women with infertility due to anovulation and over-responding to FSH treatment were randomized to receive, in addition to 37.5 IU recombinant human FSH (rFSH), either placebo or different doses of rLH (6.8, 13.6, 30 or 60 µg) daily for a maximum of 7 days. The primary efficacy endpoint was the proportion of patients who had exactly one follicle ≥16 mm on hCG day. RESULTS: Among 153 enrolled patients, the five treatment groups were similar in terms of baseline characteristics. The proportion of patients with exactly one follicle ≥16 mm ranged from 13.3% in the placebo group to 32.1% in the 30 µg rLH group (P=0.048). The pregnancy rate ranged from 10.3% in the 60 µg group to 28.6% in the 30 µg rLH group. Adverse events were similar between groups. CONCLUSIONS: In patients over-responding to FSH during ovulation induction, doses of up to 30 µg rLH/day appear to increase the proportion of patients developing a single dominant follicle (≥16 mm). Our data support the ‘LH ceiling’ concept whereby addition of rLH is able to control development of the follicular cohort.

Keywords: anovulation; follicular growth; recombinant human FSH; recombinant human LH.

* Recombinant LH Study Group: Prof. D.Healy, Clayton, Australia; Dr G.Hughes, Randwick, Australia; Dr T.Tulandi, Montreal, Canada; Dr A.N.Andersen, Copenhagen, Denmark; Dr E.Varila, Tampere, Finland; Dr C.Avril, Bois Guillaume, France; Prof. J.N.Hugues, Dr I.Cedrin Durnerin, Bondy, France; Dr Y.Michapoulos, Athens, Greece; Dr J.Soussis, Athens, Greece; Dr I.Calderon, Haifa, Israel; Prof. J.Itzkovitz, Haifa, Israel; Prof. G.Melis, Sardinia, Italy; Prof. J.Balasch, Dr F.Fábregues, Barcelona, Spain; Dr V.Caballero Fernandez, Seville, Spain; Dr A.de la Fuente, Madrid, Spain; Prof. A.Romeu, Valencia, Spain; Assoc. Prof. O.Gökmen, Ankara, Turkey; Prof. R.Pabuçcu, Ankara, Turkey; Dr R.A.Anderson, Edinburgh, UK; Prof. D.Barlow, Oxford, UK; Dr R.Fleming, Glasgow, UK; Dr S.Power, London, UK.


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