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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

Women diagnosed with early-stage endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative hysteroscopic treatment at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS, either for fertility preservation or due to contraindications to radical surgery. All procedures were performed by a single experienced surgeon.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Hysteroscopic Resection and Hormonal Therapy

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Conservatively Treated Patients1 intervention

Trial outcomes

Primary outcomes

1

Pregnancy 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
2

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
3

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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