Endometrial Receptivity Prediction During in Vitro Fertilization Using Artificial Intelligence

Sponsor
Gottsegen National Cardiovascular Institute
Study ID
NCT06717802
Status
Recruiting

Conditions

  • Infertility
  • Infertility (IVF Patients)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Study Details

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the study is voluntary, involves no additional testing or intervention beyond routine procedures, and consent can be withdrawn verbally or in writing at any time without cause or adverse consequences.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

Key Dates

First listed
Dec 5, 2024
Start date
Jun 1, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
1,500 participants (estimated)

Primary Outcome Measure

Clinical pregnancy [ Time Frame: The date of the ultrasound confirmed clinical pregnancy scheduled at 28 days following embryo transfer ]

Central Contacts

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