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Ultrasound and Histology in AEH and Early EEC Treated Conservatively
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-06-11
Completion Date
2027-06-30
Last Updated
2025-06-19
Healthy Volunteers
Not specified
Conditions
Interventions
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.
Locations (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy