ALGO3: FSH Doser for Controlled Ovarian Stimulation

Sponsor

Clínica EUGIN (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05948293

Collaborator

(none)

236

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Device: Machine learning model called IDoser Procedure: Standard clinical practice	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm 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 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. Other Names: IDoserFSH
Active Comparator: Control arm In the control arm the first dose of FSH will be determined by the clinician following standard practice.	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.

Arm

Intervention/Treatment

Experimental: Intervention arm

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

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.

Other Names:

IDoserFSH

Active Comparator: Control arm

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

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.

Outcome Measures

Primary Outcome Measures

Number of MII oocytes [3 weeks (from enrollment to oocyte pick-up)]
Total number of mature MII oocytes retrieved at oocyte pick-up

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 51 Years

Sexes Eligible for Study:

Female

Accepts 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Clínica EUGIN

Investigators

Principal Investigator: Mina Popovic, PhD, Eugin Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clínica EUGIN

ClinicalTrials.gov Identifier:

NCT05948293

Other Study ID Numbers:

ALGO3

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Clínica EUGIN

controlled ovarian stimulation

Follicle Stimulating Hormone

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Jul 17, 2023