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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China Second University Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: ZHENG Ying, Professor
• Email: 935398163@qq.com
• Phone: +8613018256012

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.