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Hum. Reprod. Advance Access originally published online on July 27, 2006
Human Reproduction 2006 21(11):2817-2822; doi:10.1093/humrep/del265
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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 use of a decremental dose regimen in patients treated with a chronic low-dose step-up protocol for WHO Group II anovulation: a prospective randomized multicentre study

J.N. Hugues1,3, I. Cédrin-Durnerin1, C.M. Howles2 On Behalf of the Recombinant FSH OI Study Group

1 Reproductive Medicine Unit, Jean Verdier Hospital, University Paris XIII, Paris, France and 2 Serono International, S.A. Chemin des mines 15 bis, Geneva, Switzerland

3 To whom correspondence should be addressed at: Reproductive Medicine Unit, Jean Verdier Hospital, University Paris XIII, Avenue du 14 Juillet, Bondy, Paris, France. E-mail: jean-noel.hugues{at}jvr.ap-hop-paris.fr

M.Amram, Marseille; A.Angelini, Perugia; A.Balen, Leeds; D.Barbereau, Bron; M.Birkhauser, Bern; A.Boujenah, Paris; V.De Leo, Siena; G.De Placido, Napoli; S.Dessole, Sassari; S.Favrin, Toulouse; E.Ferrazi, Milano; C.Gay, Strasbourg; M.Germond, Lausanne; B.Hedon, Montpellier; C.Hocke, Bordeaux; C.Jolly, Caen; E.Lamarca-Roth, Mulhouse; A.Lanzone, Roma; F.Marchand, Nantes; G.Marcolin, Lille; G.Mascaretti, Coppito; L.Moreau, Strasbourg; M.Massobrio, Torino; C.Nappi, Napoli; G.Pardi, Milano; G.Pennehouat, Chartres; E.Porcu, Bologna; M.Seibert, Mulhouse; L.Selvaggi, Bari; D.Thiers, Aix-en-Provence; P.Venturini, Genova.

BACKGROUND: In women with chronic anovulation, the choice of the FSH starting dose and the modality of subsequent dose adjustments are critical in controlling the risk of overstimulation. The aim of this prospective randomized study was to assess the efficacy and safety of a decremental FSH dose regimen applied once the leading follicle was 10–13 mm in diameter in women treated for WHO Group II anovulation according to a chronic low-dose (CLD; 75 IU FSH for 14 days with 37.5 IU increment) step-up protocol. METHODS: Two hundred and nine subfertile women were treated with recombinant human FSH (r-hFSH) (Gonal-f) for ovulation induction according to a CLD step-up regimen. When the leading follicle reached a diameter of 10–13 mm, 158 participants were randomized by means of a computer-generated list to receive either the same FSH dose required to achieve the threshold for follicular development (CLD regimen) or half of this FSH dose [sequential (SQ) regimen]. HCG was administered only if not more than three follicles ≥16 mm in diameter were present and/or serum estradiol (E2) values were <1200 pg/ml. The primary outcome measure was the number of follicles ≥16 mm in size at the time of hCG administration. RESULTS: Clinical characteristics and ovarian parameters at the time of randomization were similar in the two groups. Both CLD and SQ protocols achieved similar follicular growth as regards the total number of follicles and medium-sized or mature follicles (≥16 mm: 1.5 ± 0.9 versus 1.4 ± 0.7, respectively). Furthermore, serum E2 levels were equivalent in the two groups at the time of hCG administration (441 ± 360 versus 425 ± 480 pg/ml for CLD and SQ protocols, respectively). The rate of mono-follicular development was identical as well as the percentage of patients who ovulated and achieved pregnancy. CONCLUSIONS: The results show that the CLD step-up regimen for FSH administration is efficacious and safe for promoting mono-follicular ovulation in women with WHO Group II anovulation. This study confirms that maintaining the same FSH starting dose for 14 days before increasing the dose in step-up regimen is critical to adequately control the risk of over-response. Strict application of CLD regimen should be recommended in women with WHO Group II anovulation.

Key words: chronic low-dose step-up protocol/decremental dose protocol/ovulation induction/r-hFSH/WHO Group II anovulation


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