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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Follicle-stimulating hormone (FSH)

    Drug

    Daily subcutaneous injection of 150 IU FSH

  • Follicle-stimulating hormone (FSH)

    Drug

    Daily subcutaneous injection of 225 IU FSH

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: 150 IU FSH GroupExperimental treatment 1 intervention
Group B: 225 IU FSH GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative Live Birth Rate per Initiated Cycle

The delivery of at least one live-born infant at ≥24 weeks of gestation resulting from the first fresh embryo transfer or any subsequent frozen embryo transfer from a single stimulation cycle.

Time frame
Up to 12 months after randomization

Secondary outcomes

1

Number of Oocytes Retrieved

Total number of oocytes retrieved at oocyte pick-up.

Time frame
Up to 2 weeks
2

Incidence of Moderate/Severe OHSS

Proportion of participants developing moderate or severe OHSS according to Golan classification.

Time frame
Up to 4 weeks after oocyte retrieval
3

Total FSH Consumption

Total amount of FSH (in IU) used during the stimulation cycle.

Time frame
Up to 2 weeks
4

Clinical Pregnancy Rate

Presence of a gestational sac with fetal heartbeat on ultrasound at 7 weeks of gestation.

Time frame
7 weeks of gestation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American Hospital 2 Kosovo

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: