Medroxyprogesterone Acetate vs LNG-IUS in Early-stage Endometrioid Carcinoma and Atypical Hyperplasia Patients

Study Overview
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Brief Summary
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In modern society, endometrial cancer (EC) and atypical hyperplasia is the most frequent desease which can affect the fertility of young patients. For young patients, there is a growing need to treat tumors and fertility sparing. Advaced studies have confirmed thatfertility preservation therapy has better tumor and pregnancy outcomes in specific patients with early gynecological tumors. Clinically, evidence-based guidelines are urgently needed to guide the screening and treatment of women who are suitable for fertility preservation. Fertility-sparing treatment predominantly involves the use of oral progestins and levonorgestrel-releasing intrauterine devices, which have been shown to be feasible and safe in women with early stage EC and minimal or no myometrial invasion. However, data on the efficacy and safety of conservative management strategies are primarily based on retrospective studies.The present study aims to compared the therapeutic effect of Medroxyprogesterone acetate (MPA) and Levonorgestrel-releasing intrauterine system (LNG-IUS) in early-stage endometrioid carcinoma and atypical hyperplasia patients

Official Title
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The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma

Conditions
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Fertility Sparing

Intervention / Treatment
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* Drug: Medroxyprogesterone Acetate 500 MG Oral Tablet
* Device: Levonorgestrel-Releasing Intrauterine System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≤ 45 years old; Diagnostic curettage pathology is highly differentiated endometrioid adenocarcinoma; pelvic augmentation MRI or / and vaginal color ultrasound Doppler examination, tumor confined endometrium; No suspicious metastatic lesions; Endometrial pathological tissue specimens with strong positive expression of estrogen and progesterone receptors; Blood CA125 is normal; no progesterone therapy and contraindications to pregnancy; The patient himself has a strong desire to preserve fertility, and the patient should fully understand that fertility preservation treatment is not the standard treatment method; Conditional acceptance of close follow-up. Exclusion Criteria: type II endometrial cancer; Patients with abnormal liver and kidney function and other contraindications to progesterone therapy; Other parts of the body are concurrent or successively complicated by other malignant tumors; The patient and his/her family are unable to sign the informed consent form for any reason; Unconditional follow-up.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medroxyprogesterone acetate<br>Administered MPA at a dosage of 500 mg/d concurrently | Drug: Medroxyprogesterone Acetate 500 MG Oral Tablet<br>* 500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day<br>* Other names: MPA;|
| Experimental: LNG-IUS<br>Go through LNG-IUS insertion | Device: Levonorgestrel-Releasing Intrauterine System<br>* Uterine cavity insertion<br>* Other names: LNG-IUS, 52-mg LNG-IUS，Mirena;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | The 24-week CR rate will be calculated in two groups. | 24-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve complete response | The median CR time will be calculated in two groups | From date of randomization until the date of CR, assessed up to 24 weeks | 
| The pregnancy rate | Rate of fertility outcomes | Up to 2 years after the treatment | 
| The live-birth rate | Rate of fertility outcomes | Up to 2 years after the treatment |