150 IU vs. 225 IU FSH in Normal Responders: The OPTIMAL-DOSE Trial
Key facts
- Who runs it
- American Hospital 2 Kosovo
- Trial code
- Status
- Withdrawn
- Phase
- Phase 3
- Started
- 1 Mar 2026
- Expected to end
- 15 Jan 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Follicle-stimulating hormone (FSH)
- Record updated
- 29 October 2026
- Why it stopped
- Ethics approval was not obtained. The study was withdrawn before any participants were enrolled.
Who can take part
- Age
- 18 years to 39 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous complete fertilization failure (fertilization rate <30%)
- Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria
- Uncontrolled endocrine disorders (uncontrolled hypothyroidism, hyperprolactinemia, diabetes)
- Severe male factor (sperm count <5 million/mL, or requirement for donor sperm/TESE)
- Predicted poor or high ovarian response (AMH <1.2 or >3.5 ng/mL; AFC <8 or >20)
- Severe endometriosis (Stage III-IV per ASRM)
- Severe uterine abnormalities affecting implantation
- Contraindications to pregnancy or gonadotropins
- Participation in another clinical trial within 30 days
- Inability to provide informed consent
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 150 IU FSH GroupTreatment being tested
Participants receive a fixed daily dose of 150 IU of recombinant or urinary FSH starting on day 2-3 of the menstrual cycle, continuing until trigger day.
Treatment: Follicle-stimulating hormone (FSH)
- 225 IU FSH GroupExisting treatment, for comparison
Participants receive a fixed daily dose of 225 IU of recombinant or urinary FSH starting on day 2-3 of the menstrual cycle, continuing until trigger day.
Treatment: Follicle-stimulating hormone (FSH)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 29 October 2026