Fertility-preserving hysteroscopic treatment outcomes for endometrial cancer and atypical hyperplasia

Surgical and Obstetric Outcomes in Patients With Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia Undergoing Conservative Treatment

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
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Roma)
• Trial ID: NCT07077876 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Roma

• 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

Conditions: Endometrial Adenocarcinoma, Endometrial Hyperplasia, Fertility Preservation, Conservative Treatment Therapy, Endometrial Cancer, Atypical Endometrial Hyperplasia, Fertility-Sparing Treatment, Hysteroscopy