FSH Doser for Controlled Ovarian Stimulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Device: Machine learning model called IDoser
* Procedure: Standard clinical practice


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>In the intervention arm the first dose of FSH will be assigned by a machine learning model called IDoser. | Device: Machine learning model called IDoser<br>* 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.<br>* Other names: IDoserFSH;|
| Active Comparator: Control arm<br>In the control arm the first dose of FSH will be determined by the clinician following standard practice. | Procedure: Standard clinical practice<br>* Patients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of MII oocytes | Total number of mature MII oocytes retrieved at oocyte pick-up | 3 weeks (from enrollment to oocyte pick-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle cancellation rate | Cycle cancellation rate defined as the number of patients with no MII oocytes at OPU divided by the total number of enrolled patients | 3 weeks (from enrollment to oocyte pick-up) | 
| OHSS risk | Risk of ovarian hyperstimulation defined as levels of estradiol > 5000 pg/ml and/or a number ≥ 18 follicles measuring ≥11mm at last ultrasound check | 3 weeks (from enrollment to oocyte pick-up) | 
| Clinical pregnancy rate | Clinical pregnancy rate defined as the detection of fetal heart beat observed at 7th week of gestation, per first embryo transfer | 10 weeks (from enrollment to detection of fetal heart beat) | 
| Live birth rate | Live Birth rate, per first embryo transfer | 44 weeks (from enrollment to baby delivery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AI, controlled ovarian stimulation, Follicle Stimulating Hormone