PURPOSE: Gonal-F (Serono, Aubonne, Switzerland) is a recombinant human follicle stimulating hormone (FSH) synthesized in vitro by cells into which genes encoding for FSH subunits have been inserted. This preparation exhibits physiochemical, immunological, and pharmacological properties that bear great similarity to those of native human FSH. It has a high specific activity and can be administered subcutaneously. To compare the efficacy and safety of Gonal-F with those of urinary human FSH (Metrodin; Serono) in achieving superovulation for IVF purposes in a prospective, randomized study. METHODS:Twenty infertile patients (normo-ovulatory healthy women) were recruited for the study and allocated at random to the Gonal-F or Metrodin groups. The treatment protocol consisted of pituitary down regulation by GnRH analog (Buserelin; Hoechst, Frankfurt, Germany) employing the "long" protocol initiated at the mid-luteal phase (900 micrograms/day, intranasal administration). Gonal-F (SC) or Metrodin (IM) was injected daily (225 IU/day) starting on cycle day 3. Dose adjustment was performed, when necessary, from cycle day 7. RESULTS: Of the 20 cycles analyzed, none was canceled due to poor response. No cases of adverse effects (including local intolerance) or ovarian hyperstimulation syndrome were recorded in either group. They did not differ significantly in the following treatment-dependent variables: hormone profile, duration of FSH treatment, total FSH dose required to achieve follicular maturation, and the number of oocytes retrieved, fertilized, and replaced. CONCLUSIONS: These preliminary data concur with previous studies in demonstrating that Gonal-F is as effective and safe as Metrodin (when given in combination with a "long" protocol of GnRH analog) in inducing controlled ovarian hyperstimulation for IVF purposes. Its mode of administration (SC instead of IM) offers an additional advantage over the urinary human FSH.
RCT Entities:
PURPOSE: Gonal-F (Serono, Aubonne, Switzerland) is a recombinant human follicle stimulating hormone (FSH) synthesized in vitro by cells into which genes encoding for FSH subunits have been inserted. This preparation exhibits physiochemical, immunological, and pharmacological properties that bear great similarity to those of native human FSH. It has a high specific activity and can be administered subcutaneously. To compare the efficacy and safety of Gonal-F with those of urinary human FSH (Metrodin; Serono) in achieving superovulation for IVF purposes in a prospective, randomized study. METHODS: Twenty infertilepatients (normo-ovulatory healthy women) were recruited for the study and allocated at random to the Gonal-F or Metrodin groups. The treatment protocol consisted of pituitary down regulation by GnRH analog (Buserelin; Hoechst, Frankfurt, Germany) employing the "long" protocol initiated at the mid-luteal phase (900 micrograms/day, intranasal administration). Gonal-F (SC) or Metrodin (IM) was injected daily (225 IU/day) starting on cycle day 3. Dose adjustment was performed, when necessary, from cycle day 7. RESULTS: Of the 20 cycles analyzed, none was canceled due to poor response. No cases of adverse effects (including local intolerance) or ovarian hyperstimulation syndrome were recorded in either group. They did not differ significantly in the following treatment-dependent variables: hormone profile, duration of FSH treatment, total FSH dose required to achieve follicular maturation, and the number of oocytes retrieved, fertilized, and replaced. CONCLUSIONS: These preliminary data concur with previous studies in demonstrating that Gonal-F is as effective and safe as Metrodin (when given in combination with a "long" protocol of GnRH analog) in inducing controlled ovarian hyperstimulation for IVF purposes. Its mode of administration (SC instead of IM) offers an additional advantage over the urinary human FSH.
Authors: B Mannaerts; R de Leeuw; J Geelen; A Van Ravestein; P Van Wezenbeek; A Schuurs; H Kloosterboer Journal: Endocrinology Date: 1991-11 Impact factor: 4.736
Authors: A Cerpa-Poljak; L A Bishop; Y J Hort; C K Chin; R DeKroon; S M Mahler; G M Smith; M C Stuart; P R Schofield Journal: Endocrinology Date: 1993-01 Impact factor: 4.736
Authors: B Mannaerts; Z Shoham; D Schoot; P Bouchard; J Harlin; B Fauser; H Jacobs; F Rombout; H Coelingh Bennink Journal: Fertil Steril Date: 1993-01 Impact factor: 7.329
Authors: Alberto Romeu; Juan Balasch; José A Ruiz Balda; Pedro N Barri; Salim Daya; Jean P Auray; Gerald Duru; Ariel Beresniak; José A Peinado Journal: J Assist Reprod Genet Date: 2003-08 Impact factor: 3.412