Infertility
Conditions
Keywords
controlled ovarian stimulation, Follicle Stimulating Hormone, AI
Brief 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.
Interventions
DEVICEMachine 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.
PROCEDUREStandard clinical practice
Patients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice.
Sponsors
Clínica EUGIN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of MII oocytes | 3 weeks (from enrollment to oocyte pick-up) | Total number of mature MII oocytes retrieved at oocyte pick-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cycle cancellation rate | 3 weeks (from enrollment to oocyte pick-up) | Cycle cancellation rate defined as the number of patients with no MII oocytes at OPU divided by the total number of enrolled patients |
| OHSS risk | 3 weeks (from enrollment to oocyte pick-up) | 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 | 10 weeks (from enrollment to detection of fetal heart beat) | Clinical pregnancy rate defined as the detection of fetal heart beat observed at 7th week of gestation, per first embryo transfer |
| Live birth rate | 44 weeks (from enrollment to baby delivery) | Live Birth rate, per first embryo transfer |
Outcome results
None listed