InfertilityAI in ARTNCT04255615
Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes
A study testing AI to analyze 3 D ultrasound in people with Infertility and in Vitro Fertilization (IVF), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible IVF/ART outcomes. This tool has been utilized to accurately predict embryo quality here at Cornell. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, in Vitro Fertilization (IVF), ART
- What is being tested?
- AI to analyze 3 D ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing ovarian stimulation (including OI and IVF cycles)
- Treatment for fresh embryo transfer and cryopreservation of oocytes or embryos upfront
- Healthy male partners of the female subjects who agree to be part of the study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Nikica Zaninovic, PhD, 646-962-2764, nizanin@med.cornell.edu
Rodriq Stubbs, NP, 646-962-3276, res2011@med.cornell.edu
About this study
Official title: The Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes
The use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible IVF/ART outcomes. This tool has been utilized to accurately predict embryo quality here at Cornell. Utilizing this tool to assess objective clinical findings and predict outcomes of assisted reproductive techniques is sought, with the ultimate goal of an automated tool to reduce implicit physician bias. Within this goal, using this tool to objectively and accurately assess baseline ovarian reserve at the start of an ART cycle is proposed, using 3D sonography to image the ovary and artificial intelligence tool to objectively identify baseline antral follicle counts.
Read the detailed description
This study will collect prospective data, specifically 3D transvaginal ultrasound of ovaries at time of baseline evaluation at beginning of an ART cycle. All participants will be asked to give written consent to be included in the study. At the time of initial ultrasound that is routinely done on the first day of the ART cycle, the physician performing the ultrasound will use a 3D ultrasound transvaginal probe to perform the ultrasound and capture both 2D and 3D images. 3D ultrasound is performed routinely for patients undergoing ART and is not an investigative procedure, however is not uniformly performed at the time of the baseline ultrasound. As per standard practice, the baseline antral follicle count will be documented by the performing physician, as well as a 3D image saved to be analyzed later using AI.
Information about the medical history, treatment and outcomes will be collected as part of the study. Data maintained in the medical record as a result of standard of care monitoring for IVF and IUI will also be used for this study. This will include semen analysis (male partners if applicable) and pregnancy outcomes. For male partners, the semen analysis record will be part of the fertility history and semen analysis will be performed as standard of care with semen processing for fertilization. Additional data related to the treatment and outcomes will be collected from the medical record from the time of consent through the end of the treatment (including pregnancy outcomes).
The time commitment for subjects may take up to 1 month (time from consent signing to 3D ultrasound) and to the time of delivery if pregnant (up to 9 months). No further procedures will be performed in the study group.
- Conditions
- Infertility, in Vitro Fertilization (IVF), ART
- Being tested
- AI to analyze 3 D ultrasound
- Keywords
- Artificial Intelligence
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI to analyze 3 D ultrasoundOther
Also called z
AI to assess 3 D ultrasound to assess antral follicle count
| Study group | Role | What they receive |
|---|---|---|
| 3D Ultrasound with AI | Other | AI tool to assess antral follicle count using 3 D Ultrasound Receives: Other: AI to analyze 3 D ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of baseline antral follicle count
To assess the accuracy and feasibility of using our artificial intelligence tool to assess antral follicle count, an indicator of baseline ovarian reserve, at time of baseline ultrasound for ART compared to qAVCantral and manual follicle counts to number of total oocytes retrieved.
Measured: Baseline
Number of retrieved oocytes
To assess the accuracy and feasibility of using our artificial intelligence tool
Measured: 2 weeks
Secondary outcomes (4)
Number of mature oocytes
Number of mature oocytes (ART cycles)
Measured: 2 weeks
Number of multiple gestation
Number of multiple gestation for OI cycles.
Measured: approximately 6- 8 weeks
Number of clinical intrauterine pregnancies IVF
Clinical intrauterine pregnancies
Measured: approximately 6- 8 weeks
Number of clinical intrauterine pregnancies OI
Clinical intrauterine pregnancies
Measured: Approximately 6- 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start12 Feb 2020
- Primary completion31 Jan 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikica Zaninovic, PHD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255615
- Sponsor's protocol ID
- 19-06020306
- Acronym
- AI in ART
- Status last verified
- Dec 2025
- First submitted
- 3 Feb 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes
- ClinicalTrials.gov ID
- NCT04255615
- Acronym / sponsor ID
- AI in ART / 19-06020306
- Conditions
- Infertility, in Vitro Fertilization (IVF), ART
- Keywords
- Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 5 Feb 2020 (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 use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible IVF/ART outcomes. This tool has been utilized to accurately predict embryo quality here at Cornell. Utilizing this tool to assess objective clinical findings and predict outcomes of assisted reproductive techniques is sought, with the ultimate goal of an automated tool to reduce implicit physician bias. Within this goal, using this tool to objectively and accurately assess baseline ovarian reserve at the start of an ART cycle is proposed, using 3D sonography to image the ovary and artificial intelligence tool to objectively identify baseline antral follicle counts.
Detailed description
This study will collect prospective data, specifically 3D transvaginal ultrasound of ovaries at time of baseline evaluation at beginning of an ART cycle. All participants will be asked to give written consent to be included in the study. At the time of initial ultrasound that is routinely done on the first day of the ART cycle, the physician performing the ultrasound will use a 3D ultrasound transvaginal probe to perform the ultrasound and capture both 2D and 3D images. 3D ultrasound is performed routinely for patients undergoing ART and is not an investigative procedure, however is not uniformly performed at the time of the baseline ultrasound. As per standard practice, the baseline antral follicle count will be documented by the performing physician, as well as a 3D image saved to be analyzed later using AI.
Information about the medical history, treatment and outcomes will be collected as part of the study. Data maintained in the medical record as a result of standard of care monitoring for IVF and IUI will also be used for this study. This will include semen analysis (male partners if applicable) and pregnancy outcomes. For male partners, the semen analysis record will be part of the fertility history and semen analysis will be performed as standard of care with semen processing for fertilization. Additional data related to the treatment and outcomes will be collected from the medical record from the time of consent through the end of the treatment (including pregnancy outcomes).
The time commitment for subjects may take up to 1 month (time from consent signing to 3D ultrasound) and to the time of delivery if pregnant (up to 9 months). No further procedures will be performed in the study group.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D Ultrasound with AI | Other | Other: AI to analyze 3 D ultrasoundAI tool to assess antral follicle count using 3 D Ultrasound |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing ovarian stimulation (including OI and IVF cycles)
- Treatment for fresh embryo transfer and cryopreservation of oocytes or embryos upfront
- Healthy male partners of the female subjects who agree to be part of the study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AI to analyze 3 D ultrasoundAlso: zAI to assess 3 D ultrasound to assess antral follicle count | Other | 3D Ultrasound with AI |
Primary outcome
Number of baseline antral follicle count
Time frame: Baseline
To assess the accuracy and feasibility of using our artificial intelligence tool to assess antral follicle count, an indicator of baseline ovarian reserve, at time of baseline ultrasound for ART compared to qAVCantral and manual follicle counts to number of total oocytes retrieved.
Number of retrieved oocytes
Time frame: 2 weeks
To assess the accuracy and feasibility of using our artificial intelligence tool
4 secondary outcomes
Number of mature oocytes
Time frame: 2 weeks
Number of multiple gestation
Time frame: approximately 6- 8 weeks
Number of clinical intrauterine pregnancies IVF
Time frame: approximately 6- 8 weeks
Number of clinical intrauterine pregnancies OI
Time frame: Approximately 6- 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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.
Nikica Zaninovic, PHD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI to analyze 3 D ultrasound in people with Infertility and in Vitro Fertilization (IVF), run by Weill Medical College of Cornell University at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikica Zaninovic, PhD (646-962-2764, nizanin@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of baseline antral follicle count (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.