FSH Doser for Controlled Ovarian Stimulation (ALGO3)

Clínica EUGIN

Status: Withdrawn

Conditions: Infertility

Treatments: Procedure: Standard clinical practice; Device: Machine learning model called IDoser

Study type: Interventional

Funder types: Other

Identifiers

NCT05948293

ALGO3

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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

Treatment:

Device: Machine learning model called IDoser

Control arm

Active Comparator group

Description:

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

Treatment:

Procedure: Standard clinical practice