Ultrasound and Histology in AEH and Early EEC Treated Conservatively

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special approach to manage certain early changes in the lining of the uterus, called atypical endometrial hyperplasia (AEH), and early-stage endometrial cancer (EEC), in women who want to preserve their fertility. Instead of the usual surgery that removes the uterus, this study looks at how well ultrasound scans and tissue samples can help doctors watch these conditions while using treatments that aim to keep the uterus intact. The goal is to better understand how the uterus changes during treatment and how these changes relate to both the tissue health and the ability to have children in the future.

Women aged 18 to 45 with a confirmed diagnosis of AEH or early endometrial cancer (grades 1 or 2) who are candidates for fertility-sparing treatment may be eligible. This treatment can include surgical removal of abnormal tissue through a small scope (hysteroscopy) and/or hormone therapy with progestins. Participants will have regular ultrasounds and tissue checks to monitor progress. The study will collect information over about two years from around 50 patients to improve how doctors use ultrasound to guide and track treatment. If you fit these criteria and are interested in preserving fertility while treating these early uterine conditions, this study might be an option to discuss with your doctor.

Gender

FEMALE

Eligibility criteria

• 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.