Hum. Reprod. Advance Access originally published online on December 2, 2004
Human Reproduction 2005 20(2):390-396; doi:10.1093/humrep/deh625
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Recombinant human LH supplementation versus recombinant human FSH (rFSH) step-up protocol during controlled ovarian stimulation in normogonadotrophic women with initial inadequate ovarian response to rFSH. A multicentre, prospective, randomized controlled trial
1 Dipartimento Universitario di Scienze Ostetriche Ginecologiche e Medicina della Riproduzione, Area Funzionale di Medicina della Riproduzione ed Endoscopia Ginecologica, Università degli Studi di Napoli ‘Federico II’, Napoli, 2 Istituto Materno Infantile, Università di Palermo, Palermo, 3 Biogenesi, Casa di Cura Villa Europa all'EUR, Roma, 4 Unità Operativa Ginecologia e Ostetricia, A.O.San Giovanni di Dio e Ruggi D'Aragona, Salerno, 5 Dipartimento di Scienze Chirurgiche Generali e Specialistiche, Sezione Ginecologia e Ostetricia A, Università di Bari, Bari, 6 Dipartimento Universitario di Scienze Ginecologiche, Ostetriche e della Riproduzione, II Università di Napoli, Napoli
7 To whom correspondence should be addressed at: via Luigi Caldieri 132, 80128, Napoli, Italy. Email: alviggi{at}unina.it
BACKGROUND: In 
12–14% of young normogonadotrophic women treated with a depot GnRH agonist long protocol, the initial ovarian response to recombinant human FSH (rFSH) can be suboptimal. We have tested the hypothesis that these women may benefit from recombinant human LH (rLH) supplementation in a multicentre, prospective, randomized trial compared with patients treated with an rFSH step-up protocol. METHODS: A total of 260 young normogonadotrophic women undergoing controlled ovarian stimulation with a GnRH agonist long protocol for IVF/ICSI were enrolled. The starting dose of rFSH was 225 IU. One hundred and thirty patients with serum estradiol levels <180 pg/ml and with at least six follicles with a mean diameter >5 mm but none >10 mm on both day 5 and day 8 of stimulation were randomly allocated to two groups. From the eighth day of stimulation, women in group A (n=65) received 150 IU of rLH in addition to rFSH, while those in group B (n=65) had an increase of 150 IU in the daily dose of rFSH (step-up protocol). One hundred and thirty normally responding women continued monotherapy with rFSH and served as a further control population (group C). RESULTS: The mean number of cumulus–oocyte complexes retrieved in group A (9.0±4.3) was significantly higher (P<0.01) compared with group B (rFSH 6.1±2.6) but significantly lower compared with group C (10.49±3.7, P<0.05). Implantation and pregnancy rates were significantly lower (P<0.05) in the rFSH step-up group (10.5 and 29.3% respectively) when compared with normal responders (18.1 and 47.3% respectively). CONCLUSIONS: rLH supplementation is more effective than increasing the dose of rFSH in terms of ovarian outcome in patients with an initial inadequate ovarian response to rFSH alone.
Key words: FSH/IVF/LH/recombinant human LH/poor responders
* Italian Collaborative Group on Recombinant Human Luteinizing Hormone: Antonino Abate, Francesco Abate, Maria Perino: Centro ‘Riproduzione Umana’, Messina; Erminia Alviggi, Francesco Bertocci, Salvatore Conforti, Roberto Clarizia, Maristella D'Uva, Emmanuel Fiore, Pasquale Granata, Tiziana Pagano, Maria Teresa Varricchio: Università degli Studi di Napoli ‘Federico II’, Napoli; Rosaria Schillaci: Istituto Materno Infantile, Università di Palermo, Palermo; Simon Fishel, Leonardo Rinaldi: Biogenesi, Roma; Mariateresa Capotorto, Luigi Selvaggi: Università di Bari, Bari; Daniela Mele, Argyro Tassou: II Università di Napoli, Napoli.
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