Ultrasound and Histology in AEH and Early EEC Treated Conservatively (ULTRA-SAFE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Early Endometrial Cancer (EEC); Fertility-Sparing Treatment (FST); Atypical Endometrial Hyperplasia

Treatments: Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment

Study type: Observational

Funder types: Other

Identifiers

NCT07028242

7691

Details and patient eligibility

About

Ultra-S.A.F.E. is a multicenter, ambispective observational study investigating the ultrasound and histological characteristics of patients with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2 undergoing fertility-sparing treatment (FST). The study aims to describe pre-treatment ultrasound features, evaluate endometrial modifications during treatment, and assess histological and reproductive outcomes. It includes a prospective cohort (new patients recruited at three gynecologic oncology centers) and a retrospective cohort (patients treated conservatively since January 2023). Approximately 50 patients will be enrolled over 24 months, with clinical, ultrasound, and histological data collected. The ultimate goal is to enhance the diagnostic and monitoring role of transvaginal ultrasound (TVUS) in conservative treatment for fertility preservation.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Women aged 18-45 years.

Histologically confirmed atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2.

Candidates for fertility-sparing treatment (hysteroscopic resection and/or progestin therapy).

No prior history of invasive endometrial carcinoma.

Adequate endometrial visualization via transvaginal ultrasound (TVUS) and/or MRI.

Signed informed consent for study participation.

Exclusion criteria

Women under 18 or over 45 years.

Presence of myometrial invasion on MRI or histological analysis.

Histological diagnosis of serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma.

History of previous hysterectomy or non-conservative surgical treatment.

Contraindications to hormonal therapy (e.g., thromboembolic disease, hormone-dependent malignancies).

Pregnancy at the time of enrollment.

Lack of adequate imaging for ultrasound-based assessment.

Trial design

50 participants in 2 patient groups

Retrospective

Description:

This group includes patients with a histological diagnosis of atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-G2 who underwent hysteroscopic fertility-sparing surgery and medical treatment starting from January 2023. These patients were retrospectively identified from the Hysteroscopic Treatments Database. Only those with pre-treatment transvaginal ultrasound imaging available were included.

Treatment:

Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment

Prospective

Description:

This group includes reproductive-age women newly diagnosed with AEH or EEC G1-G2, confirmed by endometrial biopsy during diagnostic hysteroscopy, who are eligible and consenting for fertility-sparing treatment. Patients undergo baseline clinical assessment, transvaginal ultrasound, and MRI prior to hysteroscopic surgery. Fertility-sparing treatment includes hysteroscopic endometrial resection, intrauterine device (IUD) placement and/or oral progestin therapy, followed by monitoring with serial biopsies and ultrasound at 3, 6, and 12 months.

Treatment:

Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment