Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment (CHOICE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Endometrial Adenocarcinoma

Endometrial Hyperplasia

Fertility Preservation

Conservative Treatment Therapy

Treatments

Procedure: Hysteroscopic Resection and Hormonal Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT07077876

7309 (Other Identifier)

Details and patient eligibility

About

This observational study aims to evaluate the obstetric and oncological outcomes of patients diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Eligible patients include women who received hysteroscopic surgery and hormonal therapy either to preserve fertility or due to medical contraindications to standard radical surgery. Follow-up lasts 12 months.

Full description

This is a monocentric cohort study conducted at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. It includes women diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment using standardized hysteroscopic techniques performed by a single surgeon. The intervention consists of hysteroscopic lesion resection, insertion of a 52 mg levonorgestrel-releasing IUD, and in selected cases oral progestin therapy with Megestrol Acetate. The study includes both women desiring fertility preservation and patients medically unfit for radical surgery. Follow-up includes hysteroscopic biopsies at 3, 6, and 12 months. The primary objective is to assess obstetric outcomes, with secondary endpoints including oncologic outcomes.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.