Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Endometrial Hyperplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Early Endometrial Cancer (EEC) | Endometrial Endometrioid Adenocarcinoma | ALIAS | 0.85 |
| Fertility-Sparing Treatment (FST) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hysteroscopic fertility-sparing surgery and hormonal treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment
- label
- 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.
- interventionNames
- Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available