A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Rate of Regression
研究概览
简要总结
The investigators' objective is to determine the regression rate, side effects and acceptability of Mirena compared to megace in the treatment of atypical endometrial hyperplasia among women desiring fertility.
详细描述
Atypical endometrial hyperplasia is a growing clinical problem that increases the risk of carcinogenesis and negatively impacts fertility. Although oral medical treatment may lead to regression in up to 90% of patients, they are associated with adverse side effects such as weight gain, that negatively affects fertility. To-date, there has been no RCTs evaluating the performance of the Mirena Intrauterine System (IUS) with megestrol acetate (megace) (the most effective and commonly used progestogen) in treating women with atypical hyperplasia who still desire fertility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women diagnosed with atypical hyperplasia aged 21 years to 40 years
- •Keen for fertility-preserving treatment
排除标准
- •Patients who are currently undergoing treatment for atypical hyperplasia
- •Patients with a history of endometrial carcinoma
研究组 & 干预措施
Mirena Arm
The patients in the Mirena arm will have a Mirena inserted at time of recruitment of the study. An endometrial biopsy will be performed to assess for disease progression, regression or persistence after 3 months. The endometrial biopsy will be performed via bedside endometrial sampling or hysteroscopic biopsy. As Mirena can be used for treatment of atypical hyperplasia as well as endometrial protection (decreases the risk of endometrial hyperplasia recurrence), the option of keeping or changing the Mirena during biopsy will be discussed with the patient.
干预措施: Mirena (Drug)
Megace Arm
The patients in the megace arm will have be prescribed 3 months of oral megace at time of recruitment of the study. An endometrial biopsy will be performed to assess for disease progression, regression or persistence after 3 months. The endometrial biopsy will be performed via bedside endometrial sampling or hysteroscopic biopsy.
干预措施: Megace (Drug)
结局指标
主要结局
Rate of Regression
时间窗: Review in 3 months, maximum up to 9 months of treatment.
Participants will be reviewed in clinic every 3 months. An endometrial biopsy via hysteroscopy or bedside endometrial sampling will be performed to assess persistence, progression or resolution of the disease.
Time taken for regression of the disease
时间窗: Review in 3 months, maximum up to 9 months of treatment.
Participants will be reviewed in clinic every 3 months. An endometrial biopsy via hysteroscopy or bedside endometrial sampling will be performed to assess persistence, progression or resolution of the disease.
次要结局
- Side Effects(Through study completion, an average of 9 months.)
- Patient Acceptability(Review in 9th months.)
研究者
Phoon Wai Leng Jessie
Assistant Professor
KK Women's and Children's Hospital