Effect of Fertility-sparing Therapy of Early Endometrial Cancer

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.

Detailed Description
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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.

Official Title
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Effect of Fertility-sparing Therapy of Early Endometrial Cancer

Conditions
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Endometrial Cancer, Fertility

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages of no more than 40 with a strong desire of fertility preservation International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1 2 with lesion confined in endometrium pathology expression of progestin receptors (PRs) and estrogen receptors Exclusion Criteria: not eligible for pregnancy or delivery evidence of suspected extrauterine or distant metastasis complicated with any other malignancy severe medical complications contraindication of oral progestin uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: BMI≥25 group with metformin<br>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, | Drug: Metformin<br>* Metformin is given to patients 1-1.5g/d.<br>|
| No Intervention: BMI≥25 group without metformin<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | Histologically shows absence of pathological hyperplasia or carcinoma. | through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Pregnancy test shows pregnancy after complete response. | through study completion, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remission time, Endometrial cancer, Atypical hyperplasia, Fertility-preserving, Recurrence, Pregnancy, Progesterone receptor