A randomised controlled trial of 300 versus 225 IU recombinant FSH for ovarian stimulation in predicted normal responders by antral follicle count

Please cite this paper as: Jayaprakasan K, Hopkisson J, Campbell B, Johnson I, Thornton J, Raine‐Fenning N. A randomised controlled trial of 300 versus 225 IU recombinant FSH for ovarian stimulation in predicted normal responders by antral follicle count. BJOG 2010;117:853–862. Objective To test the hypothesis that among women predicted to have a normal ovarian response, ovarian stimulation using 300 IU follicle‐stimulating hormone (FSH) results in the retrieval of more mature oocytes than 225 IU during in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) treatment. Design Prospective randomised controlled study. Setting University‐based assisted conception unit. Population A cohort of 131 women predicted to have a normal ovarian response to gonadotrophin stimulation, based on antral follicle count. Methods Subjects undergoing their first cycle of IVF/ICSI were randomised to receive a fixed daily dose of 300 (experimental arm) or 225 IU (control arm) of recombinant FSH (Gonal‐F). Main outcome measures Number of mature oocytes retrieved and live birth rates. Results The number (mean ± standard deviation) of mature oocytes retrieved (8.2 ± 5.0 versus 9.0 ± 4.8, for 300 and 225 IU, respectively; P = 0.34) was similar in each group. There were no differences between the 300‐ and 225 IU arms in live birth rates (31 versus 41%, respectively; P = 0.25), cycle cancellations resulting from insufficient ovarian response (0 versus 6.1%, respectively; P = 0.12), and prevalence of moderate (3.1 versus 3.0, respectively; P = 1.0) and severe (0 versus 1.5%, respectively; P = 1.0) ovarian hyperstimulation syndrome. Conclusions The use of a higher daily dose of 300 IU of recombinant FSH for ovarian stimulation does not improve the number of mature oocytes retrieved, or live birth rates, among women with a predicted normal response during conventional IVF/ICSI.