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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medroxyprogesterone acetate | Experimental | Administered MPA at a dosage of 500 mg/d concurrently |
|
| LNG-IUS | Experimental | Go through LNG-IUS insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medroxyprogesterone Acetate 500 MG Oral Tablet | Drug | 500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | The 24-week CR rate will be calculated in two groups. | 24-week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hengzi Sun, Ph.D | Contact | +86 18811151901 | summerel1990@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hua Li, Ph.D | Beijing Chao Yang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bei Jing Chao-Yang Hospital | Recruiting | Beijing | Beijing Municipality | 100025 | China |
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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|
| Levonorgestrel-Releasing Intrauterine System | Device | Uterine cavity insertion |
|
|
| Up to 2 years after the treatment |
| The live-birth rate | Rate of fertility outcomes | Up to 2 years after the treatment |
| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |