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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Patients underwent hysteroscopic resection of atypical endometrial hyperplasia (AEH) or grade 1-2 endometrial adenocarcinoma (EAC) using a 15 Fr mini-resectoscope. Depending on the case, the procedure included visual D\&C or a combined technique. At the end of the procedure, a 52 mg levonorgestrel-releasing intrauterine device (LNG-IUD) was inserted. In patients with EAC G2 or poor prognostic markers (e.g., MMR deficiency), oral progestin therapy with Megestrol Acetate (160 mg daily) was added. Follow-up included hysteroscopic endometrial biopsy at 3, 6, and 12 months to assess response.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
RECRUITINGPregnancy Rate
Proportion of participants who achieve a clinical pregnancy (intrauterine gestational sac with fetal heartbeat) after conservative treatment.
Time frame: Within 12 months from histologically confirmed complete response
Miscarriage Rate
Proportion of pregnancies that end in miscarriage (pregnancy loss \< 20 weeks' gestation) among women who became pregnant after treatment.
Time frame: Within 12 months from histologically confirmed complete response
Live Birth Rate
Proportion of pregnancies resulting in at least one live-born infant after treatment.
Time frame: Within 12 months from histologically confirmed complete response
Disease-Free Interval
Evaluation of time without disease recurrence from date of conservative treatment for EAC or AEH.
Time frame: Up to 12 months after treatment
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