NCT05948293

FSH Doser for Controlled Ovarian Stimulation

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Clínica EUGIN · Academic / Other
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DEVICE	Machine learning model called IDoser	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.
PROCEDURE	Standard clinical practice	Patients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2023-07-17
• Last updated: 2024-01-26