150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial
ConditionInfertility, Female
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorAmerican Hospital 2 Kosovo
About this 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.
Eligibility criteria
Qualifiers
Body Mass Index (BMI) 18-30 kg/m².
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.
Disqualifiers
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).
Severe uterine abnormalities affecting implantation.
Trial design
Treatments tested in this trial
- Follicle-stimulating hormone (FSH)
- Follicle-stimulating hormone (FSH)
Treatment groups
440 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov