FSH Doser for Controlled Ovarian Stimulation (ALGO3)

Randomized Investigation With an AI Powered Medical Device to Select the First Dose of FSH for Controlled Ovarian Stimulation

The study aims to evaluate the effectiveness of an individualized FSH dosing model called IDoser in controlled ovarian stimulation (COS) for assisted reproduction. The randomized, controlled, multicenter trial involves 236 first cycle IVF patients, who will be assigned to either the intervention arm (using the IDoser model) or the control arm (standard clinician-determined dosing). The primary outcome is the number of mature oocytes retrieved, with the hypothesis of non-inferiority for the intervention arm. Secondary outcomes include cycle cancellations, risk of ovarian hyperstimulation syndrome (OHSS), and pregnancy and live birth rates.

Participants will be blinded to arm allocation. The research team will also be blinded, with the exception of the data coordinator. The medical team, with the exception of the ones assigned to care for the participants, will also be blinded to arm allocation. The embryology laboratory team will also be blinded.

In the intervention arm the first dose of FSH will be assigned by a machine learning model called IDoser.

In the control arm the first dose of FSH will be determined by the clinician following standard practice.

Patients in the intervention arm will be prescribed the first dose of FSH by IDoser, that will take into account the age of the patient, BMI, AFC and AMH. These data will be retrieved from the patient's clinical file after their first visit to the clinic, after providing the patient with informed consent documentation.

Patients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice.

Cycle cancellation rate defined as the number of patients with no MII oocytes at OPU divided by the total number of enrolled patients

Risk of ovarian hyperstimulation defined as levels of estradiol > 5000 pg/ml and/or a number ≥ 18 follicles measuring ≥11mm at last ultrasound check

Clinical pregnancy rate defined as the detection of fetal heart beat observed at 7th week of gestation, per first embryo transfer

Inclusion Criteria: First IVF cycles Use of autologous oocytes Use of FSH on the first day of stimulation (which can be combined with luteinizing hormone, LH). Exclusion Criteria: Natural ovarian stimulation cycles (without Controlled ovarian stimulation) Cycles where FSH is not measured in International Units (IU).