Fully human glyco-optimized recombinant FSH (follitropin epsilon) - a randomized, comparator-controlled phase 2 clinical trial

Abstract Research Question To determine the standard treatment dose of follitropin epsilon for ovarian stimulation in the context of in-vitro fertilization treatment. Design 247 women aged ≤37 years were treated with either 52.5, 75, 112.5, or 150 IU follitropin epsilon daily or 150 IU every other day or 150 IU follitropin alfa daily in a long GnRH-agonist protocol. The study was performed as randomized, assessor-blind, comparator-controlled, six-armed phase II trial in 8 fertility clinics in two European countries. Results Primary: None of the follitropin epsilon doses showed superiority for the main outcome measure, i.e., number of follicles ≥12 mm. Follitropin epsilon 75 IU produced mostly similar results as follitropin alfa 150 IU. Secondary: Stronger effects of follitropin epsilon above 75 IU were seen for secondary outcome measures like hormones (estradiol and inhibin B) and oocyte numbers. Conclusions 75 IU of daily follitropin epsilon results in similar ovarian response as compared to a standard dose of 150 IU follitropin alfa. This dose could be tested in phase III.