InfertilityNCT06717802
Endometrial Receptivity Prediction During in Vitro Fertilization Using Artificial Intelligence
An observational study of Infertility and Infertility (IVF Patients), run by Gottsegen National Cardiovascular Institute at 1 site in Hungary.
Trial summary
The investigators plan to use artificial intelligence to analyse vaginal ultrasound images of the uterine lining (endometrium) taken during routine IVF treatment, which may predict implantation success during IVF treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Infertility (IVF Patients)
- How many people
- 1,500 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jun 2025to 31 Dec 2028
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who volunteer for IVF treatment at participating infertility centres
Who may be able to join
- Female patient 18-40 years, for whom IVF is indicated
- Maximum 3 unsuccessful previous embryo transfers
- Only cycles in which single blastocyst is transferred
Who cannot join
- Congenital uterine anomalies, fibroids, adenomyosis, Asherman-syndrome or any other conditions resulting in malformation of the uterus
- Presence of hydrosalpinx
- Endometriosis
- Planned freeze-all cycle
- Positive hepatitis B, hepatitis C or HIV screening test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Dunamenti REK Reprodukcios Kozpont
Budapest, 1205
Gabor Spanik, +36702478175, spanik.gabor@dunamentirek.hu
About this study
Official title: Endometrial Receptivity Prediction During in Vitro Fertilization Using Artificial Intelligence Analysis of Vaginal Ultrasound Images
The investigators plan to use artificial intelligence to analyse vaginal ultrasound images of the uterine lining (endometrium) taken during routine IVF treatment, which may predict implantation success during IVF treatment.
Participation in the study is voluntary, involves no additional testing or intervention beyond routine procedures, and consent can be withdrawn verbally or in writing at any time without cause or adverse consequences.
Read more
Over a three-year period, the trial is expected to enrol approximately 1,500 patients between the ages of 18 and 40 who are indicated for IVF treatment and who volunteer for treatment.
Patients enrolled in the study will not be required to attend more clinic visits during treatment than they would otherwise have to. During the trial, certain patient-specific data (age, indication for treatment, body mass index), stimulation-specific data (duration of stimulation, type and dose of drug, endometrial thickness), ultrasound scans and outcome-specific data (treatment failure, biochemical pregnancy, clinical pregnancy) will be collected. The data will be stored in a secure database. The data collected during the study will only be accessible to the professionals involved in the study and no information, including personal data, will be disclosed to third parties.
Read the detailed description
Infertility affects one in six people globally over the duration of their reproductive lives. For successful IVF treatment, three essential things are needed: a euploid embryo, receptive endometrium and in case of frozen embryos, the exact timing of the transfer. Several methods are available for evaluating embryos, such as: microscopic evaluation (e.g. Gardner grade), genetic tests (PGT), biochemical tests (non-invasive PGT). Furthermore, morphological and morphokinetic evaluation is possible using time-lapse video surveillance systems that are evaluated using artificial intelligence. The most common method for testing the receptivity of the endometrium is the determination of the largest diameter measured in the mid-sagittal plane. A thickness between 7 and 10 mm is considered the cut-off for successful implantation. Further studies were conducted on the level of the serum and endometrial progesterone, the volume, echogenicity, peristalsis of the endometrium, the flow conditions in it and the success of implantation. The predictive value of hysteroscopy, 3D ultrasound and the role of ultrasound elastography to predict pregnancy outcome has been investigated. The above-mentioned tests for endometrial receptivity have not been widely used in practice, and there is currently no method for predicting endometrial receptivity in everyday practice.
As the quality of imaging has improved, the focus has shifted to analyzing the pattern of the endometrium, the latest research using artificial intelligence.
The aim of this study is to investigate whether segmentation and analysis of the endometrium using artificial intelligence in vaginal ultrasound images taken during stimulation and on the day of transfer can help to more accurately determine the receptivity of the endometrium. The significance of this is that in case of poor implantation chances it is possible to freeze the embryo(s) and have the opportunity to implant the embryo in a subsequent natural or hormone replacement therapy cycle, possibly with better chances.
- Conditions
- Infertility, Infertility (IVF Patients)
- Keywords
- assisted reproduction, Artificial intelligence (AI), Endometrial receptivity, Embryo implantation, Ultrasound imaging
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Clinical pregnancy: pregnancy can be confirmed through ultrasound visualization of the gestational sac or heartbeat
Measured: The date of the ultrasound confirmed clinical pregnancy scheduled at 28 days following embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gottsegen National Cardiovascular Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dunamenti REK Reprodukcios Kozpont
- Responsible party
- Principal investigator, Márton Kolossváry, Gottsegen National Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717802
- Sponsor's protocol ID
- endoAI
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Receptivity Prediction During in Vitro Fertilization Using Artificial Intelligence Analysis of Vaginal Ultrasound Images
- ClinicalTrials.gov ID
- NCT06717802
- Acronym / sponsor ID
- endoAI
- Conditions
- Infertility, Infertility (IVF Patients)
- Keywords
- assisted reproduction, Artificial intelligence (AI), Endometrial receptivity, Embryo implantation, Ultrasound imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Gottsegen National Cardiovascular InstituteUniversity, hospital or other
- Collaborators
- Dunamenti REK Reprodukcios Kozpont
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Dec 2024 (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 investigators plan to use artificial intelligence to analyse vaginal ultrasound images of the uterine lining (endometrium) taken during routine IVF treatment, which may predict implantation success during IVF treatment.
Participation in the study is voluntary, involves no additional testing or intervention beyond routine procedures, and consent can be withdrawn verbally or in writing at any time without cause or adverse consequences.
Over a three-year period, the trial is expected to enrol approximately 1,500 patients between the ages of 18 and 40 who are indicated for IVF treatment and who volunteer for treatment.
Patients enrolled in the study will not be required to attend more clinic visits during treatment than they would otherwise have to. During the trial, certain patient-specific data (age, indication for treatment, body mass index), stimulation-specific data (duration of stimulation, type and dose of drug, endometrial thickness), ultrasound scans and outcome-specific data (treatment failure, biochemical pregnancy, clinical pregnancy) will be collected. The data will be stored in a secure database. The data collected during the study will only be accessible to the professionals involved in the study and no information, including personal data, will be disclosed to third parties.
Detailed description
Infertility affects one in six people globally over the duration of their reproductive lives. For successful IVF treatment, three essential things are needed: a euploid embryo, receptive endometrium and in case of frozen embryos, the exact timing of the transfer. Several methods are available for evaluating embryos, such as: microscopic evaluation (e.g. Gardner grade), genetic tests (PGT), biochemical tests (non-invasive PGT). Furthermore, morphological and morphokinetic evaluation is possible using time-lapse video surveillance systems that are evaluated using artificial intelligence. The most common method for testing the receptivity of the endometrium is the determination of the largest diameter measured in the mid-sagittal plane. A thickness between 7 and 10 mm is considered the cut-off for successful implantation. Further studies were conducted on the level of the serum and endometrial progesterone, the volume, echogenicity, peristalsis of the endometrium, the flow conditions in it and the success of implantation. The predictive value of hysteroscopy, 3D ultrasound and the role of ultrasound elastography to predict pregnancy outcome has been investigated. The above-mentioned tests for endometrial receptivity have not been widely used in practice, and there is currently no method for predicting endometrial receptivity in everyday practice.
As the quality of imaging has improved, the focus has shifted to analyzing the pattern of the endometrium, the latest research using artificial intelligence.
The aim of this study is to investigate whether segmentation and analysis of the endometrium using artificial intelligence in vaginal ultrasound images taken during stimulation and on the day of transfer can help to more accurately determine the receptivity of the endometrium. The significance of this is that in case of poor implantation chances it is possible to freeze the embryo(s) and have the opportunity to implant the embryo in a subsequent natural or hormone replacement therapy cycle, possibly with better chances.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who volunteer for IVF treatment at participating infertility centres
Key inclusion criteria (3 listed)
- Female patient 18-40 years, for whom IVF is indicated
- Maximum 3 unsuccessful previous embryo transfers
- Only cycles in which single blastocyst is transferred
Key exclusion criteria (5 listed)
- Congenital uterine anomalies, fibroids, adenomyosis, Asherman-syndrome or any other conditions resulting in malformation of the uterus
- Presence of hydrosalpinx
- Endometriosis
- Planned freeze-all cycle
- Positive hepatitis B, hepatitis C or HIV screening test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical pregnancy
Time frame: The date of the ultrasound confirmed clinical pregnancy scheduled at 28 days following embryo transfer
Clinical pregnancy: pregnancy can be confirmed through ultrasound visualization of the gestational sac or heartbeat
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 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Infertility (IVF Patients), run by Gottsegen National Cardiovascular Institute at 1 site in Hungary.
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 5 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 11 Sep 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 Hungary. 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 Marton Jozsef Kolossvary (+36301789227, marton.kolossvary@gokvi.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy (time frame: The date of the ultrasound confirmed clinical pregnancy scheduled at 28 days following embryo transfer). 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 11 Sep 2025.