Endometrial Receptivity Prediction During in Vitro Fertilization Using Artificial Intelligence

NCT06717802 | Recruiting

• 1 other identifier: endoAI
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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in the study is voluntary, involves no additional testing or intervention beyond routine procedures, and consent can be withdrawn verbally or in writing at any time without cause or adverse consequences.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.

Conditions

Infertility; Infertility (IVF Patients)

Keywords

assisted reproduction; Artificial intelligence (AI); Endometrial receptivity; Embryo implantation; Ultrasound imaging

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy

  Clinical pregnancy: pregnancy can be confirmed through ultrasound visualization of the gestational sac or heartbeat

  The date of the ultrasound confirmed clinical pregnancy scheduled at 28 days following embryo transfer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who volunteer for IVF treatment at participating infertility centres

You may qualify if:

• Female patient 18-40 years, for whom IVF is indicated
• Maximum 3 unsuccessful previous embryo transfers
• Only cycles in which single blastocyst is transferred

You may not qualify if:

• 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

Sponsors & Collaborators

• Gottsegen National Cardiovascular Institute: lead
• Dunamenti REK Reprodukcios Kozpont: collaborator

Study Sites (1)

Dunamenti REK Reprodukcios Kozpont

Budapest, 1205, Hungary

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Marton Jozsef Kolossvary

CONTACT

+36301789227; marton.kolossvary@gokvi.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Education and Research

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

HU (1)