NCT07028242

Ultrasound and Histology in AEH and Early EEC Treated Conservatively

Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Fertility-Sparing Treatment (FST)
• Atypical Endometrial Hyperplasia
• Early Endometrial Cancer (EEC)

Interventions

Type	Name	Description
PROCEDURE	Hysteroscopic fertility-sparing surgery and hormonal treatment	Patients undergo hysteroscopic endometrial resection using the Mazzon "three-step" technique or tissue removal device (TRD), depending on the lesion type. Following surgery, hormonal treatment is administered either via intrauterine device (IUD) or oral progestin. Monitoring includes serial endometrial biopsies and transvaginal ultrasounds at 3, 6, and 12 months.

Timeline

• Start date: 2025-06-11
• Primary completion: 2025-12-30
• Completion: 2027-06-30
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: Italy