Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- difference AMH between thalidomide group and other treatment group
研究概览
简要总结
The effectiveness of thalidomide in treating inflammatory bowel disease has been widely recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on ovarian reserve function.Therefore, this study was to investigate the influence of thalidomide on function of ovarian reserve.
详细描述
It will be divided two groups of patients according to the treatment itself . One group was treated by thalidomide, the other was other treatment excluding. It will detect the function of ovarian reserve before and after treatment in both two groups, to investigate the influence of thalidomide on function of ovarian reserve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years old Diagnosis of patients with CD
排除标准
- •Pregnancy or lactation Period of women have fertility program during the study Treatment not foot eight weeks after last IFX Central or peripheral nerve disease Abnormal in liver and renal function Heart function failure Malignant tumor Active tuberculosis
研究组 & 干预措施
thalidomide
use thalidomide tablet by mouth, every night for at least 6 months
干预措施: Thalidomide (Drug)
other treatment
the treatment include infliximab, azathioprine or enteral nutrition at least 6 months
干预措施: infliximab, azathioprine (Drug)
other treatment
the treatment include infliximab, azathioprine or enteral nutrition at least 6 months
干预措施: enteral nutrition (Other)
结局指标
主要结局
difference AMH between thalidomide group and other treatment group
时间窗: 1 year
Anti-mullerian hormone（AMH）, as an important index to monitor the function of ovarian reserve, is majorly secreted by preantral follicles and antral follicles without fluctuation during menstrual cycle, not affected by hormone, and its change is earlier than sex hormone.
difference AFC between thalidomide group and other treatment group
时间窗: 1 year
The foundational follicles at 5- 10 mm of both ovaries were determined and the sum of antral follicles of both sides of ovaries was as antral follicles communicate (AFC)
difference FSH between thalidomide group and other treatment group
时间窗: 1 year
Follicle stimulating hormone,a kind of hormone
difference E2 between thalidomide group and other treatment group
时间窗: 1 year
estradiol，a kind of hormone
次要结局
未报告次要终点
研究者
pengxiang
Principal Investigator
Sixth Affiliated Hospital, Sun Yat-sen University