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

Starting soon · Phase 3

Conditions studied: Infertility, Female

In brief

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.

Key facts

Study ID

NCT07346235

Run by

American Hospital 2 Kosovo

People needed

440

Starts

2026-03-01

Expected to finish

2029-01-15

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Previous complete fertilization failure (fertilization rate <30%).
• Severe male factor (sperm count <5 million/mL, or requirement for donor sperm/TESE).
• Uncontrolled endocrine disorders (uncontrolled hypothyroidism, hyperprolactinemia, diabetes).
• Contraindications to pregnancy or gonadotropins.
• Participation in another clinical trial within 30 days.
• Inability to provide informed consent.

Where it is running

• American Hospital Kosova — Pristina, Kosovo

Full record on ClinicalTrials.gov

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