Using a hormonal device to preserve fertility in patients with early endometrial cancer and atypical hyperplasia

Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma

This study is testing if a hormonal device can help women under 40 with early endometrial cancer and atypical hyperplasia keep their fertility while monitoring their health and pregnancy outcomes.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: N/A to 40 Years
• Sex: Female
• Sponsor: West China Second University Hospital (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT03463252 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the Levonorgestrel-Releasing Intrauterine System (LNG-IUS) as a fertility-preserving treatment for women diagnosed with atypical endometrial hyperplasia and early-stage endometrial carcinoma. The study focuses on assessing the pathology response and pregnancy outcomes in participants while also monitoring for potential side effects. Eligible patients are those under 40 years old who wish to preserve their fertility and meet specific histological and clinical criteria. The trial involves interventions with progesterone, Mirena®, and GnRH agonists.

Who should consider this trial

Good fit: Ideal candidates are women aged 40 or younger with a confirmed diagnosis of well-differentiated endometrioid adenocarcinoma who desire to preserve their fertility.

Not a fit: Patients with contraindications to the involved drugs or those with more advanced stages of cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could allow women with early endometrial cancer to preserve their fertility while effectively managing their condition.

How similar studies have performed: While similar approaches have been explored, this specific application of LNG-IUS for fertility preservation in endometrial cancer is relatively novel.

Eligibility criteria

For Patients With Endometrial Cancer：

Inclusion Criteria:

* ≤40 years of age:
* Having a strong desire for fertility preservation;
* Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry;
* Disease limited to the endometrium (stage 1A) on MRI;
* Serum CA125/199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary);
* Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.

Exclusion Criteria:

* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs;
* Patients have lynch syndrome (LS);
* Patients have contraindications for pregnancy;
* Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible);
* Patients refuse to participate in clinical follow-up or sign the informed consent form.

For Patients With Endometrial atypical hyperplasia：

Inclusion Criteria:

* ≤ 40 years of age
* Having a strong desire for fertility preservation
* Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists
* Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up

Exclusion Criteria:

* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs
* Patients have contraindications for pregnancy
* Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible)
* Patients refuse to participate in clinical follow-up or sign the informed consent form.

Where this trial is running

Chengdu, Sichuan

• West China Second University Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: ZHENG Ying, Professor

Conditions Endometrial Cancer; Atypical Endometrial Hyperplasia