FSH Doser for Controlled Ovarian Stimulation

Infertility Clinical Trial

— ALGO3  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05948293
• Other study ID #: ALGO3
• Status: Withdrawn
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Clínica EUGIN
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clínica EUGIN

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of MII oocytes	Total number of mature MII oocytes retrieved at oocyte pick-up	3 weeks (from enrollment to oocyte pick-up)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Live birth rate	Live Birth rate, per first embryo transfer	44 weeks (from enrollment to baby delivery)