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150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial
Sponsor: American Hospital 2 Kosovo
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.
Official title: OPTIMAL-DOSE: A Randomized, Open-Label, Non-Inferiority Trial Comparing Fixed Daily Doses of 150 IU Versus 225 IU of Follicle-Stimulating Hormone in Predicted Normal Responders Undergoing In Vitro Fertilization/Intracytoplasmic Sperm Injection
Key Details
Gender
FEMALE
Age Range
18 Years - 39 Years
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2026-03-01
Completion Date
2029-01-15
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Follicle-stimulating hormone (FSH)
Daily subcutaneous injection of 150 IU FSH
Follicle-stimulating hormone (FSH)
Daily subcutaneous injection of 225 IU FSH
Locations (1)
American Hospital Kosova
Pristina, Kosovo