title: A prospective, randomized, double-blind clinical trial to study the efficacy and efficiency of a fixed dose of recombinant follicle stimulating hormone (Puregon) in women undergoing ovarian stimulation.
abstract: A prospective, randomized, double-blind, multicentre (n = 5) study was conducted to compare the influence of either a 100 or 200 IU daily fixed-dose regimen of recombinant follicle stimulating hormone (FSH) on the number of oocytes retrieved and the total dose used in down-regulated women undergoing ovarian stimulation. Fertilization was done by intracytoplasmic sperm injection or conventional in-vitro fertilization. A total of 199 women were treated with FSH, 101 subjects with 100 IU and 98 subjects with 200 IU. In subjects of the 200 IU treatment group, significantly more oocytes were retrieved compared to the 100 IU group (10.6 versus 6.2 oocytes, P < 0.001). The total dose needed to develop at least three follicles with a diameter of > or = 17 mm was significantly lower in the 100 IU treatment group (1114 IU versus 1931 IU, P < 0.001). In the low-dose group, significantly lower serum concentrations of oestradiol, progesterone and FSH were observed at the day of human chorionic gonadotrophin administration. Although more cycle cancellations due to low response were seen in the 100 IU group (n = 24 versus n = 3), the clinical pregnancy rate per started cycle was similar (24.7% in the 100 IU group versus 23.3% in the 200 IU group). In the high-dose group, more side-effects, in particular more cases of ovarian hyperstimulation syndrome, were noted. It is concluded that compared to 200 IU, the use of a 100 IU fixed dose is less efficacious in terms of the number of oocytes retrieved, but more efficient as indicated by a lower total dose.
authors.affiliation: NV Organon, Oss, The Netherlands.
authors.forename: H J
authors.initials: HJ
authors.lastname: Out
authors.forename: S
authors.initials: S
authors.lastname: Lindenberg
authors.forename: A L
authors.initials: AL
authors.lastname: Mikkelsen
authors.forename: T
authors.initials: T
authors.lastname: Eldar-Geva
authors.forename: D L
authors.initials: DL
authors.lastname: Healy
authors.forename: A
authors.initials: A
authors.lastname: Leader
authors.forename: F J
authors.initials: FJ
authors.lastname: Rodriguez-Escudero
authors.forename: J A
authors.initials: JA
authors.lastname: Garcia-Velasco
authors.forename: A
authors.initials: A
authors.lastname: Pellicer
mesh_terms: D002064:Buserelin / Q000627:therapeutic use; D006063:Chorionic Gonadotropin / Q000008:administration & dosage; D004311:Double-Blind Method; D004958:Estradiol / Q000097:blood; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D043373:Follicle Stimulating Hormone, Human; D006801:Humans; D016729:Leuprolide / Q000627:therapeutic use; D008845:Microinjections; D017274:Nafarelin / Q000627:therapeutic use; D010062:Ovulation Induction; D011247:Pregnancy; D011374:Progesterone / Q000097:blood; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D006063:Chorionic Gonadotropin; D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins; D017274:Nafarelin; D011374:Progesterone; D004958:Estradiol; D005640:Follicle Stimulating Hormone; D016729:Leuprolide; D002064:Buserelin