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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective | 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. |
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| Prospective | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopic fertility-sparing surgery and hormonal treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial ultrasound changes during medical treatment | Evaluation of ultrasound modifications of the endometrium throughout conservative treatment, correlated with hysteroscopic and histological findings. | Baseline, 6 months, and 12 months post-treatment initiation. |
| Ultrasound predictors of treatment response |
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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.
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The study is limited to female participants, as it investigates conditions affecting the endometrium. Eligibility is determined based on biological sex, rather than gender identity, due to the nature of the pathology and the focus on fertility-sparing treatment in patients with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2.
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonia Carla Testa | Contact | 0630156399 | antoniacarla.testa@policlinicogemelli.it | |
| Federica Pozzati | Contact | 0630156399 | federica.pozzati@guest.policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonia Carla Testa | Fondazione Policlinico Universitario Agostino Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00168 | Italy |
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Comparison of pre-treatment ultrasound features between patients who achieve remission and those with persistent disease after 6 months of therapy. |
| Baseline and 6 months post-treatment. |
| 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 | Baseline and 12 months post-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 | Baseline |
| Comparison of ultrasound and MRI findings | Assessment of ultrasound imaging in comparison to MRI for pre-treatment evaluation of endometrial lesions | Baseline |
| ID | Term |
|---|---|
| D004714 | Endometrial Hyperplasia |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007434 | Intrauterine Devices |
| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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