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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Maternal and Child Health Hospital of Hubei Province |
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The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
This is a prospective, multi center, open, randomized, controlled clinical trial. All endometrial cancer (EC) or atypical hyperplasia (AH) patients who met the fertility-sparing indications in the hospitals involved in this study were recruited. Then the investigators conducted assessment, treatment and follow up according to the standard procedure. General information, therapeutic regimen, side effects, oncological and pregnant results were collected for risk factors analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI≥25 group with metformin | Experimental | Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels, |
|
| BMI≥25 group without metformin | No Intervention | Patients with BMI≥25kg/m2 in the none intervention group are treated with MPA 0.25g/d alone and are followed-up of baseline data, hormone levels, and endometrial pathology every 3 months until 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin is given to patients 1-1.5g/d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Histologically shows absence of pathological hyperplasia or carcinoma. | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Pregnancy test shows pregnancy after complete response. | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Pathology shows atypical hyperplasia or carcinoma again after complete response. | through study completion, an average of 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianliu Wang, Professor | Contact | 010-88324381 | wangjianliu1203@163.com | |
| Rong Zhou, Professor | Contact | 010-88324350 | zhourong@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianliu Wang, Professor | Department of Obstetrics and Gynecology, Peking University People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23021687 | Result | Gallos ID, Yap J, Rajkhowa M, Luesley DM, Coomarasamy A, Gupta JK. Regression, relapse, and live birth rates with fertility-sparing therapy for endometrial cancer and atypical complex endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2012 Oct;207(4):266.e1-12. doi: 10.1016/j.ajog.2012.08.011. Epub 2012 Aug 10. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |