Fertility-preserving hysteroscopic treatment outcomes for endometrial cancer and atypical hyperplasia
Official title: Surgical and Obstetric Outcomes in Patients With Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia Undergoing Conservative Treatment
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07077876 · Data updated 2026-11-12
This project tests whether removing lesions by hysteroscopy combined with hormonal therapy helps women with endometrial cancer or atypical hyperplasia preserve fertility and achieve good pregnancy and cancer-control outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | June 20, 2025 |
| Main results expected | June 30, 2025 |
| Study ends | January 20, 2026 |
| Registry record updated | July 22, 2025 |
| Trial ID | NCT07077876 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with histologically confirmed endometrial adenocarcinoma or atypical endometrial hyperplasia who underwent hysteroscopic resection at the Gemelli center and who desire fertility preservation or cannot undergo radical surgery.
✕Probably not a fit
Patients with non-endometrioid histologic subtypes, known other causes of infertility, those under 18, or those who did not receive hysteroscopic resection are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This monocentric cohort follows women with endometrial adenocarcinoma or atypical endometrial hyperplasia treated conservatively at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Patients underwent standardized hysteroscopic lesion resection performed by a single experienced surgeon, insertion of a 52 mg levonorgestrel-releasing intrauterine device, and selected use of oral megestrol acetate. The cohort includes women desiring fertility preservation and patients medically unfit for radical surgery, with hysteroscopic biopsies scheduled at 3, 6, and 12 months for follow-up. The primary outcome is obstetric results, with secondary endpoints including oncologic outcomes and safety measures.
Why it matters
Potential benefit: If successful, this approach could allow some women to avoid radical hysterectomy, retain fertility, and still achieve effective cancer control.
How similar studies have gone: Prior small cohorts and case series of hysteroscopic resection combined with progestin therapy or a levonorgestrel IUD have reported promising remission and pregnancy rates, but larger controlled data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18 years or older. * Histological diagnosis of endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH). * Patients who underwent conservative treatment with hysteroscopic resection at the CLASS Hysteroscopy Center, performed by a single experienced surgeon (U.C.). * Patients treated conservatively due to medical contraindications to radical surgery (e.g., severe comorbidities). * Signed informed consent for participation in the study. Exclusion Criteria: * Patients with other known causes of infertility. * Patients with non-endometrioid histological subtypes of endometrial adenocarcinoma. * Patients under 18 years of age. * Patients who did not provide informed consent for participation.
Where it's running
-
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Ursula Catena — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Ursula Catena
- Email: ursula.catena@policlinicogemelli.it
- Phone: +393382760021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.