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

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.

• Hysteroscopic Resection and Hormonal Therapy (Procedure): 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.

Primary outcomes

• Pregnancy Rate [Within 12 months from histologically confirmed complete response]: Proportion of participants who achieve a clinical pregnancy (intrauterine gestational sac with fetal heartbeat) after conservative treatment.
• Miscarriage Rate [Within 12 months from histologically confirmed complete response]: Proportion of pregnancies that end in miscarriage (pregnancy loss < 20 weeks' gestation) among women who became pregnant after treatment.
• Live Birth Rate [Within 12 months from histologically confirmed complete response]: Proportion of pregnancies resulting in at least one live-born infant after treatment.

Secondary outcomes

• Disease-Free Interval [Up to 12 months after treatment]: Evaluation of time without disease recurrence from date of conservative treatment for EAC or AEH.

Sex: Female, ages: 18 Years to any

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.

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• Ursula Catena, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS