A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Anti-Mullerian hormone (AMH) serum level
研究概览
简要总结
This clinical trial aims to test in female patients with systemic lupus erythematosus (SLE). The main question it seeks to answer is whether etonogestrel implants can protect ovarian reserve function in patients with SLE. Participants will be randomly divided into a test group and a control group. The test group will be implanted subcutaneously with etongestrel for one year. Researchers won't intervene in the control group. After three months of drug-eluting, researchers will compare measures of ovarian reserve function in the test and control groups to see if etonogestrel implants can protect ovarian reserve function in patients with SLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Systemic lupus erythematosus was confirmed
- •18-37 years old
排除标准
- •History of sex chromosome abnormalities
- •History of abnormal thyroid function
- •History of abnormal adrenal function
- •History of pituitary disease
- •History of sexual hormone drug use in the past 3 months
- •History of ovarian tumors or invasive ovarian operations
- •Have a birth plan in the next 1 year
- •Ovarian failure
研究组 & 干预措施
Etonogestrel implants group
Women will be subjected to etonogestrel implant (68mg) insertion.
干预措施: Etonogestrel (Drug)
结局指标
主要结局
Anti-Mullerian hormone (AMH) serum level
时间窗: one year and three months
The serum AMH levels of the two groups will be compared one year and three months after enrollment.
次要结局
- Follicle-stimulating hormone (FSH) serum level(one year and three months)
- luteinizing hormone (LH) serum level(one year and three months)
- Estradiol (E2) serum level(one year and three months)
- Number of antral follicle(one year and three months)