150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial
This is a single-center, randomized, open-label, non-inferiority trial comparing two fixed daily doses of follicle-stimulating hormone (FSH): 150 IU versus 225 IU in women with predicted normal ovarian response undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with a gonadotropin releasing hormone (GnRH) antagonist protocol. The primary objective is to determine whether the 150 IU dose is noninferior to the 225 IU dose regarding the cumulative live birth rate per initiated cycle. Secondary objectives include comparing oocyte yield, incidence of OHSS, treatment costs, and patient-reported outcomes.
Body Mass Index (BMI) 18-30 kg/m². [+5]
Predicted poor or high ovarian response (AMH <1.2 or >3.5 ng/mL; AFC <8 or >20). [+9]