NCT05948293

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2024

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

July 6, 2023

Last Update Submit

January 25, 2024

Conditions

Infertility

Keywords

controlled ovarian stimulationFollicle Stimulating HormoneAI

Outcome Measures

Primary Outcomes (1)

  • Number of MII oocytes

    Total number of mature MII oocytes retrieved at oocyte pick-up

    3 weeks (from enrollment to oocyte pick-up)

Secondary Outcomes (4)

  • Cycle cancellation rate

    3 weeks (from enrollment to oocyte pick-up)

  • OHSS risk

    3 weeks (from enrollment to oocyte pick-up)

  • Clinical pregnancy rate

    10 weeks (from enrollment to detection of fetal heart beat)

  • Live birth rate

    44 weeks (from enrollment to baby delivery)

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Procedure: Standard clinical practice

Interventions

Machine learning model called IDoserDEVICE

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.

Also known as: IDoserFSH
Intervention arm
Standard clinical practicePROCEDURE

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

Control arm

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First IVF cycles
  • Use of autologous oocytes
  • Use of FSH on the first day of stimulation (which can be combined with luteinizing hormone, LH).

You may not qualify if:

  • Natural ovarian stimulation cycles (without Controlled ovarian stimulation)
  • Cycles where FSH is not measured in International Units (IU).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38212837DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mina Popovic, PhD

    Eugin Group

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 17, 2023

Study Start

June 1, 2024

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share