Human Reproduction, Vol. 18, No. 2, 314-322,
February 2003
© 2003 European Society of Human Reproduction and Embryology
Clinical evidence for an LH ‘ceiling’ effect induced by administration of recombinant human LH during the late follicular phase of stimulated cycles in World Health Organization type I and type II anovulation
1 Serono International, Reproductive Health Clinical Development Unit, Geneva, Switzerland, 2 Department of Obstetrics and Gynecology, Kaplan Medical Center, Rehovot, Israel and 3 Department of Obstetrics and Gynaecology, University of Edinburgh Centre for Reproductive Biology, Edinburgh, UK
4 To whom correspondence should be addressed at: Serono International, 15bis Chemin des Mines, CH-1202 Geneva, Switzerland
BACKGROUND: The objective of these studies was to test the hypothesis that over-dosing with recombinant human LH (rLH) during the late follicular phase would suppress the development of follicles. METHODS: Two double-blind studies were conducted. In study A, WHO I anovulatory patients received treatment with rFSH and rLH. When at least one follicle reached a mean diameter of 10–13 mm, patients were randomized using a computer-generated randomization list (stratified by centre) to rFSH and rLH (225 IU/day) (n = 8) or rLH alone (n = 6) or rFSH alone (n = 6). In study B, WHO II anovulatory patients with a hyper-responsive FSH were randomized to rLH (225 IU/day) (n = 4) or rLH 450 IU/day (n = 8) or placebo (n = 5). RESULTS: Study A: the mean number of follicles 
11 mm was 4.2 ± 0.3 in the rFSH group, 1.5 ± 0.7 in the rLH group and 6.0 ± 2.3 in the rFSH/rLH group (P = 0.07). 0/8 patients presented follicular growth arrest in the rFSH group, but 4/6 in the rLH group and 1/6 in the rFSH/rLH did. Study B: 5/12 patients presented follicular growth arrest in the rLH groups, but none in the placebo group. The mean number of follicles 11 mm was 4.6 ± 1.8 for the placebo group, 2.5 ± 1.9 for the rLH 225 IU group and 4.2 ± 1.4 in the rLH 450 IU group (not significant). CONCLUSIONS: Results of this pilot study suggest that rLH alone can trigger follicular growth arrest in a significant number of patients, suggesting the existence of an ‘LH ceiling’ during late follicular maturation.
Key words: anovulation/follicular growth/recombinant FSH/recombinant LH
* Clinical Investigators: Prof. S.Franks, London, UK, Prof. D.Baird Edinburgh, UK; Prof. S.Smith, Cambridge, UK; Prof. R.Homburg, Israel; Prof. C.Flamigni and Dr M.Filicori, Bologna, Italy; Dr Fusi, Pisa, Italy; Prof. J.Schoemaker, Amsterdam, The Netherlands. These studies were partially presented at the Annual Meeting of the European Society of Human Reproduction and Embryology in Bologna, 2000 (Abstracts).
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