Large multicentre, observational study of a new 2:1 formulation of follitropin alfa and lutropin alfa in assisted reproductive technology (ART) in routine clinical practice

Abstract

OBJECTIVE: A new 2:1 formulation of follitropin alfa and lutropin alfa (150 IU recombinant human follicle-stimulating hormone [FSH]:75 IU recombinant human luteinizing hormone [LH]; Pergoveris®) is available for follicular development in women with severe LH and FSH deficiency. DESIGN: A non-interventional, observational study evaluated the use of this new formulation in routine clinical practice in ART. MATERIALS AND METHODS: Between October 2007 and November 2008, 19 German IVF centres participated. Routine data for stimulated IVF and intracytoplasmic sperm injection were prospectively entered into an electronic database. RESULTS: A total of 919 ART cycles from 857 patients were documented: 303 patients were poor responders and 93 had low basal LH; 58.7% were aged ≥35 years. Mean (SD) duration of stimulation was 10.8 (2.6) days. Human chorionic gonadotrophin was administered in 877 (95.4%) cycles, oocyte pick-up was performed in 858 (93.4%) cycles and 741 (89.2%) cycles resulted in embryo transfer. The mean (SD) number of oocytes retrieved per patient was 8.6 (5.6), 6.8 (79.5%) of which were mature oocytes. Two pronuclei were fertilized in a mean (SD) 4.1 (3.1) cases (62.5% of inseminated/injected oocytes). One, two and three embryos were transferred in 17.4%, 62.9% and 19.7% of cases, respectively (mean number 2.02 [0.61]). The implantation rate per embryo transferred was 23.8%, with a clinical pregnancy rate per transfer of 27.5%. Two cases (0.27%) of ovarian hyperstimulation syndrome grade III were observed; one resulted in hospitalization. Five extrauterine pregnancies (0.67%) were reported. CONCLUSIONS: The use of this 2:1 formulation for ovarian stimulation during routine ART procedures was effective in achieving clinical pregnancies and was associated with a favourable safety profile. This formulation seems to be beneficial in patients aged ≥35 years, poor responders and those with low LH.