Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia
Atypical Endometrial Hyperplasia, Fertility Issues, Overweight and Obesity
About this trial
This is an interventional treatment trial for Atypical Endometrial Hyperplasia
Eligibility Criteria
Inclusion Criteria:
1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg/m2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.
5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.
Exclusion Criteria:
- Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance < 30 mL/min)
- Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.
- Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
- Those who require hysterectomy or other methods other than conservative treatment.
- Known or suspected pregnancy.
- Those who has contraindications to use progestin.
- Deep vein thrombosis, stroke, myocardial infarction.
- Severe joint lesions that prevent walking or movement.
- untreated or recurrent pelvic inflammatory disease (PID)
- an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
- Cervical dysplasia
- Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus
- allergic to the LNG-IUS components
- uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out.
Notes: the last 6 criteria are only applied for patients with LNG-IUS.
Sites / Locations
- Obstetrics and Gynecology Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
overweight MA+ILI
overweight LNG-IUS+ILI
obese MA+ILI
obese LNG-IUS+ILI
enrolled overweight (24kg/m2≤BMI<28kg/m2) patients will receive megestrol acetate 160mg po qd plus weight management
enrolled overweight (24kg/m2≤BMI<28kg/m2) patients will be treated with LNG-IUS plus weight management
enrolled obese (BMI≥28kg/m2) patients will receive megestrol acetate 160mg po qd plus weight management
enrolled obese (BMI≥28kg/m2) patients will be treated with LNG-IUS plus weight management