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.
None
None
The study population consists of women of reproductive age (18-45 years) diagnosed with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2, who are eligible for fertility-sparing treatment. Participants are recruited from three gynecologic oncology centers (Rome, Naples, and Turin) and classified into prospective (newly enrolled) and retrospective (previously treated since January 2023) cohorts. The study focuses on analyzing endometrial ultrasound features, assessing response to conservative therapy, and evaluating reproductive outcomes in patients undergoing hysteroscopic resection and/or progestin therapy.
Cohort
Other
Hysteroscopic fertility-sparing surgery and hormonal treatment
Procedure/SurgeryPatients 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.
Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment
Analysis of pre-treatment ultrasound features of the endometrium and/or endometrial lesions, correlating findings with histological data and treatment outcomes.
Endometrial ultrasound changes during medical treatment
Evaluation of ultrasound modifications of the endometrium throughout conservative treatment, correlated with hysteroscopic and histological findings.
Ultrasound predictors of treatment response
Comparison of pre-treatment ultrasound features between patients who achieve remission and those with persistent disease after 6 months of therapy.
Endometrial ultrasound characteristics and reproductive success
Analysis of pre-treatment ultrasound features in patients who achieve pregnancy versus those with negative reproductive outcomes within 12 months of treatment
Correlation between ultrasound and molecular profiling
Investigation of potential associations between endometrial ultrasound characteristics and molecular markers of atypical endometrial hyperplasia or endometrial carcinoma
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
