FSH Doser for Controlled Ovarian Stimulation (ALGO3)

January 25, 2024 updated by: Clínica EUGIN

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of MII oocytes
Time Frame: 3 weeks (from enrollment to oocyte pick-up)
Total number of mature MII oocytes retrieved at oocyte pick-up
3 weeks (from enrollment to oocyte pick-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycle cancellation rate
Time Frame: 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
3 weeks (from enrollment to oocyte pick-up)
OHSS risk
Time Frame: 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
3 weeks (from enrollment to oocyte pick-up)
Clinical pregnancy rate
Time Frame: 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
10 weeks (from enrollment to detection of fetal heart beat)
Live birth rate
Time Frame: 44 weeks (from enrollment to baby delivery)
Live Birth rate, per first embryo transfer
44 weeks (from enrollment to baby delivery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica EUGIN

Investigators

  • Principal Investigator: Mina Popovic, PhD, Eugin Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALGO3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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