FSH Doser for Controlled Ovarian Stimulation

NCT ID: NCT05948293

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-12-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention arm

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

Group Type: EXPERIMENTAL

Machine learning model called IDoser

Intervention Type: 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.

Control arm

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

Group Type: ACTIVE_COMPARATOR

Standard clinical practice

Intervention Type: PROCEDURE

Patients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice.

Interventions

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.

Intervention Type: DEVICE

Standard clinical practice

Patients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice.

Intervention Type: PROCEDURE

Other Intervention Names

IDoserFSH

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clínica EUGIN

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mina Popovic, PhD

Role: PRINCIPAL_INVESTIGATOR

Eugin Group

References

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.

Reference Type: DERIVED

PMID: 38212837 (View on PubMed)

Other Identifiers

ALGO3

Identifier Type: -

Identifier Source: org_study_id