An observational study in Fertility-Sparing Treatment (FST), Atypical Endometrial Hyperplasia and Early Endometrial Cancer (EEC), sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
110 studies on the registry are indexed under Endometrial Hyperplasia; 38 are open to participants now.
This study's planned enrollment of 50 is below the median of 125 across 32 observational studies indexed under Endometrial Hyperplasia.
Browse Endometrial Hyperplasia studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women aged 18-45 years.
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 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.
to hormonal therapy (e.g., thromboembolic disease, hormone-dependent ).
Pregnancy at the time of enrollment.
Lack of adequate imaging for ultrasound-based assessment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment
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.
Procedure: 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.
Also known as: Endometrial resection Hormonal therapy Intrauterine device (IUD) placement Oral progestin therapy
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.
Time frame: Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy.
Endometrial ultrasound changes during medical treatment
Evaluation of ultrasound modifications of the endometrium throughout conservative treatment, correlated with hysteroscopic and histological findings.
Time frame: Baseline, 6 months, and 12 months post-treatment initiation.
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.
Time frame: 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
Time frame: 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
Time frame: Baseline
Comparison of ultrasound and MRI findings
Assessment of ultrasound imaging in comparison to MRI for pre-treatment evaluation of endometrial lesions
Time frame: Baseline
Start is estimated for Jun 2025; primary completion for Dec 2025, 6 months later.
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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