Weight management combined with hormonal treatment for women with endometrial atypical hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of weight management alongside either a levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese women diagnosed with endometrial atypical hyperplasia (EAH) who desire to preserve their fertility. The study aims to enhance treatment outcomes by addressing obesity, which is known to negatively impact response rates to fertility-sparing therapies. Participants will undergo an intensive lifestyle intervention focusing on diet, exercise, and behavioral changes, while receiving hormonal treatment. The goal is to improve complete remission rates and pregnancy outcomes in this patient population.

Why it matters

Who can join: the full rules

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:

1. 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)
2. 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.
3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
4. Those who require hysterectomy or other methods other than conservative treatment.
5. Known or suspected pregnancy.
6. Those who has contraindications to use progestin.
7. Deep vein thrombosis, stroke, myocardial infarction.
8. Severe joint lesions that prevent walking or movement.
9. untreated or recurrent pelvic inflammatory disease (PID)
10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
11. Cervical dysplasia
12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus
13. allergic to the LNG-IUS components
14. 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.

Where it's running

• Obstetrics and Gynecology Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: XIAOJUN CHEN, PhD — Obstetrics & Gynecology Hospital of Fudan University
• Study coordinator: WEIWEI SHAN, PhD
• Email: danweiwei7468@fckyy.org.cn
• Phone: 8613817813106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.