P91. Oocyte fertilization rate, embryo transfer, and user satisfaction with follitropin alfa in real-world assisted reproductive technology clinical practice: a multicenter, prospective, open, non-interventional study

Inka Wiegratz (DE), Regina Schneidereit (DE), Peter Sydow (DE), Katrin Pribbernow (DE), Christoph Keck (DE)

[Wiegratz] VivaNeo Kinderwunschpraxis Frankfurt, [Schneidereit] TEVA GmbH, [Sydow] VivaNeo Praxisklinik Sydow, [Pribbernow] Kinderwunschzentrum Magdeburg, [Keck] amedes Holding GmbH

Context – Ovaleap® (follitropin alfa), a recombinant human follicle-stimulating hormone, has shown therapeutic equivalence in efficacy and safety to Gonal-f® for controlled ovarian stimulation (COS) in a randomized controlled clinical trial in infertile women using assisted reproductive technology (ART). Both treatments were similar in median number of embryos obtained and transferred. High user satisfaction with the Ovaleap® pen was demonstrated in this study. Objective – To examine fertilization rate, embryo transfer, and user satisfaction with Ovaleap®. Methods – Multicenter, prospective, non-interventional study. Recruitment was planned for 1 year. Interim analysis examined women who received Ovaleap® dose and had Visit 3. Patient(s) – Women 18-40 years old (n=155) at specialized reproductive medicine centers in Germany, undergoing first routine ART using in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) following COS with Ovaleap®. Intervention(s) - Analysis of real world data of COS cycles using Ovaleap® in GnRH antagonist protocol. Main Outcome Measure(s) –Fertilization rate using IVF/ ICSI; number of transferred embryos; user satisfaction with the Ovaleap® pen. Result(s) – Mean duration of COS with Ovaleap® was 9.8+1.7 days (median=10.0), and mean total Ovaleap® dose was 1752.7±539.0 IU (median=1650.0). The mean number of metaphase-II oocytes was 8.6±6.1 (median=8.0). Mean percentage fertilization rate of fertilized oocytes in the 2- pro nucleus-stage using IVF/ ICSI (n=142; 10 women excluded with metaphase-II oocytes=0, 3 woman with missing data) was 69.8%±30.0% (median=70.7%). By ART procedure, mean percentage fertilization rate using IVF (n=39) was 60.0%±25.6% (median=60.0%) and using ICSI (n=103) was 73.5%±30.9% (median=75.0%). Mean number of transferred embryos was 1.8+0.4 (median=2.0). Clinical pregnancy was documented in 52 women (33.5%). User satisfaction and convenience with the Ovaleap® pen was high with 96.1% (149/155) of women reporting they were satisfied/very satisfied. Conclusions – The effectiveness of COS and higher user satisfaction with the Ovaleap® pen appear to extend to real-world ART clinical practice, including IVF and ICSI treatment using GnRH antagonist protocol.