Human Reproduction, Vol. 15, No. 7, 1446-1451,
July 2000
© 2000 European Society of Human Reproduction and Embryology
Induction of final follicular maturation and early luteinization in women undergoing ovulation induction for assisted reproduction treatment—recombinant HCG versus urinary HCG
Geneva, Switzerland
Correspondence: E.Loumaye, Ares-Serono Scientific and Medical Communication Department, 15 bis Chemin des Mines, CH-1202 Geneva, Switzerland
This multicentre, double-blind, double-dummy, randomized, parallel-group study compared the efficacy and safety of recombinant human chorionic gonadotrophin (rHCG) (Ovidrel®) and urinary HCG (uHCG) (Profasi®) for inducing final follicular maturation and early luteinization in women undergoing ovulation induction for assisted reproduction treatment. Following long down-regulation and stimulation with recombinant human FSH (rFSH) (Gonal-F®), a total of 190 women received a single, s.c. injection of either 250 µg rHCG or 5000 IU uHCG. For evaluable patients (n = 172), the mean number of oocytes retrieved per patient (primary efficacy endpoint) was 11.6 for rHCG and 10.6 for uHCG (not significant). The mean number of mature oocytes was statistically higher (P = 0.027) for the rHCG group than the uHCG (9.4 versus 7.1). Serum progesterone concentrations on day 1 and days 6–7 post-HCG, and serum HCG concentrations at all post-HCG time points were statistically significantly in favour of rHCG. The clinical pregnancy rate was somewhat higher (not significant) in the rHCG group (33 versus 25%) as was the live birth rate (27 versus 23%, not significant). Both treatments were well tolerated, though the incidence of adverse events was significantly higher in the uHCG group (45.1 versus 22.7%, P = 0.0004). The incidence of injection-site reactions was significantly lower in the rHCG group (P = 0.0001). In conclusion, for triggering ovulation, rHCG seems to have significant advantages compared with uHCG in terms of number of mature oocytes retrieved, luteal progesterone and local tolerance.
Key words: follicular maturation/IVF/ovulation induction/rHCG/uHCG
The following staff from Ares-Serono Reproductive Health Clinical Development Unit contributed to the conception, conduct and analysis of the study: L.Maislisch, D.Warne, S.Bologna, E.Loumaye. The following clinical investigators participated in the conception and conduct of the study: J.Bellaisch-Allart, Service de Gynécologie et Obstétrique, Hôpital Jean Rostand, Sèvres, France; P.Dellenbach, Service de Gynécologie et Obstétrique, 19, rue Louis Pasteur, Schiltigheim, France; F.A.Leidenberger, Gemeinschaftspraxis, Hamburg, Germany; M.Scholtes, Gemeinschaftspraxis, Dusseldorf, Germany; R.Fischer, Fertility Center Hamburg, Hamburg, Germany; B.Fisch, IVF Unit, Department of Obstetrics and Gynecology, Beilison Medical Center, Petah-Tikva, Israel; G.B.Melis, Instituto di Ginecologia, Ostetricia & Fisiopatologia della Umana, Università di Cagliari, Cagliari, Italy; J.L.H.Evers, Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands; M.Wikland, Fertilitetcentrum AB, Gothenburg, Sweden; J.Mills, Assisted Conception Unit, Ninewells Hospital and Medical School, Dundee, UK
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