150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial (NCT07346235) | Clinical Trial Compass
Not Yet RecruitingPhase 3
150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial
Kosovo440 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range18 Years – 39 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Body Mass Index (BMI) 18-30 kg/m².
✓. Predicted normal ovarian reserve:
✓. Anti-Müllerian Hormone (AMH) 1.2-3.5 ng/mL (measured within 12 months), AND Antral Follicle Count (AFC) 8-20 (both ovaries combined, measured on day 2-5 of the cycle).
✓. First or second IVF/ICSI cycle.
✓. Planned GnRH antagonist protocol.
✓. Both ovaries present and accessible.
✓. Written informed consent provided voluntarily.
Exclusion criteria
✕. Predicted poor or high ovarian response (AMH \<1.2 or \>3.5 ng/mL; AFC \<8 or \>20).
✕. Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria.
✕. Severe endometriosis (Stage III-IV per ASRM).