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Seeking financial support.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | In the intervention arm the first dose of FSH will be assigned by a machine learning model called IDoser. |
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| Control arm | Active Comparator | In the control arm the first dose of FSH will be determined by the clinician following standard practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Machine learning model called IDoser | Device | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mina Popovic, PhD | Eugin Group | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38212837 | Derived | Correa N, Cerquides J, Arcos JL, Vassena R, Popovic M. Personalizing the first dose of FSH for IVF/ICSI patients through machine learning: a non-inferiority study protocol for a multi-center randomized controlled trial. Trials. 2024 Jan 11;25(1):38. doi: 10.1186/s13063-024-07907-2. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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.
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| Standard clinical practice | Procedure | Patients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice. |
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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) |