InfertilityALGO3NCT05948293
FSH Doser for Controlled Ovarian Stimulation
A study testing Machine learning model called IDoser and Standard clinical practice in people with Infertility, run by Clínica EUGIN.
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… Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Machine learning model called IDoser and Standard clinical practice
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- First IVF cycles
- Use of autologous oocytes
- Use of FSH on the first day of stimulation (which can be combined with luteinizing hormone, LH).
Who cannot join
- Natural ovarian stimulation cycles (without Controlled ovarian stimulation)
- Cycles where FSH is not measured in International Units (IU).
About this study
Official title: 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.
- Conditions
- Infertility
- Being tested
- Machine learning model called IDoser, Standard clinical practice
- Keywords
- controlled ovarian stimulation, Follicle Stimulating Hormone, AI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine learning model called IDoserDevice
Also called IDoserFSH
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.
Standard clinical practiceProcedure or surgery
Patients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | In the intervention arm the first dose of FSH will be assigned by a machine learning model called IDoser. Receives: 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. Receives: Procedure: Standard clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MII oocytes
Total number of mature MII oocytes retrieved at oocyte pick-up
Measured: 3 weeks (from enrollment to oocyte pick-up)
Secondary outcomes (4)
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
Measured: 3 weeks (from enrollment to oocyte pick-up)
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
Measured: 3 weeks (from enrollment to oocyte pick-up)
Clinical pregnancy rate
Clinical pregnancy rate defined as the detection of fetal heart beat observed at 7th week of gestation, per first embryo transfer
Measured: 10 weeks (from enrollment to detection of fetal heart beat)
Live birth rate
Live Birth rate, per first embryo transfer
Measured: 44 weeks (from enrollment to baby delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study startJun 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Seeking financial support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica EUGIN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mina Popovic, PhD, Principal investigator, Eugin Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948293
- Sponsor's protocol ID
- ALGO3
- Acronym
- ALGO3
- Status last verified
- Jan 2024
- First submitted
- 6 Jul 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38212837
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Investigation With an AI Powered Medical Device to Select the First Dose of FSH for Controlled Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT05948293
- Acronym / sponsor ID
- ALGO3 / ALGO3
- Conditions
- Infertility
- Keywords
- controlled ovarian stimulation, Follicle Stimulating Hormone, AI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Seeking financial support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clínica EUGINUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Machine learning model called IDoserIn the intervention arm the first dose of FSH will be assigned by a machine learning model called IDoser. |
| Control arm | Active comparator | Procedure: Standard clinical practiceIn the control arm the first dose of FSH will be determined by the clinician following standard practice. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- First IVF cycles
- Use of autologous oocytes
- Use of FSH on the first day of stimulation (which can be combined with luteinizing hormone, LH).
Key exclusion criteria (2 listed)
- Natural ovarian stimulation cycles (without Controlled ovarian stimulation)
- Cycles where FSH is not measured in International Units (IU).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Machine learning model called IDoserAlso: IDoserFSHPatients 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. | Device | Intervention arm |
| Standard clinical practicePatients in the control group will be prescribed their first dose of FSH by the clinician according to standard clinical practice. | Procedure or surgery | Control arm |
Primary outcome
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
4 secondary outcomes
Cycle cancellation rate
Time frame: 3 weeks (from enrollment to oocyte pick-up)
OHSS risk
Time frame: 3 weeks (from enrollment to oocyte pick-up)
Clinical pregnancy rate
Time frame: 10 weeks (from enrollment to detection of fetal heart beat)
Live birth rate
Time frame: 44 weeks (from enrollment to baby delivery)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 38212837Correa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mina Popovic, PhD principal investigator
Eugin Group
Questions about this trial
What is this clinical trial studying?
A study testing Machine learning model called IDoser and Standard clinical practice in people with Infertility, run by Clínica EUGIN.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of MII oocytes (time frame: 3 weeks (from enrollment to oocyte pick-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.