NCT03289403已完成2 期
The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- The Number of Participants Who Achieved clinical Pregnancy
研究概览
简要总结
The aim of the work is to determine whether the use of immunomodulatory drugs could improve the reproductive of outcome of infertile patients who have autoimmune thyroiditis with positive autoimmune antibodies undergoing IVF-ET.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.
排除标准
- •All patients who have other autoimmune diseases especially antiphospholipid syndrome, hepatitis c viral disease.
- •Patients who have any medical disorders ( eg. D.M. HTN .Epilepsy ....)
研究组 & 干预措施
Study group
Experimental
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D and immunomodulatory drugs(prednisolone, hydroxychloroquine, azathioprin, IV immunoglobulins)
干预措施: Immunomodulatory (Drug)
Control group
Active Comparator
Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D.
干预措施: Thyroxine (Drug)
结局指标
主要结局
The Number of Participants Who Achieved clinical Pregnancy
时间窗: 6 weeks after embryo transfer
次要结局
- The Number of Participants Who Achieved Ongoing Pregnancy(18 weeks after embryo transfer)
研究者
研究点 (1)
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