Clinical Trial

150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial

Study acronym: OPTIMAL-DOSE
Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07346235
Lead Sponsor American Hospital 2 Kosovo
Conditions Infertility, Female
Enrollment 440 participants
Start Date 2026-03-01
Primary Completion 2028-01-01 (estimated)
Study Completion 2029-01-15 (estimated)
Updated on ClinicalTrials.gov 2026-01-16