Fertility-Sparing Treatment (FST)ULTRA-SAFENCT07028242
Ultrasound and Histology in AEH and Early EEC Treated Conservatively
An observational study of Fertility-Sparing Treatment (FST) and Atypical Endometrial Hyperplasia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fertility-Sparing Treatment (FST), Atypical Endometrial Hyperplasia, Early Endometrial Cancer (EEC)
- What is being tested?
- Hysteroscopic fertility-sparing surgery and hormonal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jun 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
Official title: Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.
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
- Fertility-Sparing Treatment (FST), Atypical Endometrial Hyperplasia, Early Endometrial Cancer (EEC)
- Being tested
- Hysteroscopic fertility-sparing surgery and hormonal treatment
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic fertility-sparing surgery and hormonal treatmentProcedure or surgery
Also called Endometrial resection Hormonal therapy Intrauterine device (IUD) placement Oral progestin therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment | |
| 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. Receives: Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy.
Secondary outcomes (5)
Endometrial ultrasound changes during medical treatment
Evaluation of ultrasound modifications of the endometrium throughout conservative treatment, correlated with hysteroscopic and histological findings.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline
Comparison of ultrasound and MRI findings
Assessment of ultrasound imaging in comparison to MRI for pre-treatment evaluation of endometrial lesions
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start11 Jun 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility-Sparing Treatment (FST)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Carla Testa, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028242
- Sponsor's protocol ID
- 7691
- Acronym
- ULTRA-SAFE
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.
- ClinicalTrials.gov ID
- NCT07028242
- Acronym / sponsor ID
- ULTRA-SAFE / 7691
- Conditions
- Fertility-Sparing Treatment (FST), Atypical Endometrial Hyperplasia, Early Endometrial Cancer (EEC)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 11 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatmentThis 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. |
| Prospective | – | Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatmentThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic fertility-sparing surgery and hormonal treatmentAlso: Endometrial resection Hormonal therapy Intrauterine device (IUD) placement Oral progestin therapyPatients 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. | Procedure or surgery | Prospective, Retrospective |
Primary outcome
Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment
Time frame: Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy.
Analysis of pre-treatment ultrasound features of the endometrium and/or endometrial lesions, correlating findings with histological data and treatment outcomes.
5 secondary outcomes
Endometrial ultrasound changes during medical treatment
Time frame: Baseline, 6 months, and 12 months post-treatment initiation.
Ultrasound predictors of treatment response
Time frame: Baseline and 6 months post-treatment.
Endometrial ultrasound characteristics and reproductive success
Time frame: Baseline and 12 months post-treatment
Correlation between ultrasound and molecular profiling
Time frame: Baseline
Comparison of ultrasound and MRI findings
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
Related trials for Fertility-Sparing Treatment (FST)
Not yet recruitingPhase 2
Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer
Endometrial Atypical Hyperplasia, Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia
Recruiting
PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer
Endometrial Cancer, Endometrioid Carcinoma
RecruitingPhase 2
Intrauterine Injection of Type III Collage in FST of EC/AEH
Atypical Endometrial Hyperplasia, Endometrial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonia Carla Testa principal investigator
Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility-Sparing Treatment (FST) and Atypical Endometrial Hyperplasia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonia Carla Testa (0630156399, antoniacarla.testa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment (time frame: Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.