An Interventional pilot study to assess the efficacy of Thymosin therapy in patients with recurrent pregnancy loss with immune dysregulation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ongoing Pregnancy rate
研究概览
简要总结
Thymosin α1is a potential treatment that can be dosed in combination with standard of care in patients with RPL.
The aim of administration of Thymosin α1 in RPL patients is to evaluate the Efficacy and safety of Thymosin α1 as an add-on therapy to standard of care (SOC) in Patients with Recurrent Pregnancy Loss (RPL) with altered immunoprofile.Interventional pilot study.
After the diagnosis of Recurrent Pregnancy Loss (RPL), patients undergo immunoprofiling. In this process, the ratio of Th1 to Th2 cytokines is measured. If the ratio is low, indicating higher TNF-alpha and lower IL-10 levels, it suggests a disturbance in immune tolerance. Based on this ratio, the grading of immune dysregulation is performed.
The efficiency of thymosin therapy in improving Assisted Reproductive Technology (ART) outcomes is then assessed and compared across mild, moderate, and severe dysregulation levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •History of recurrent pregnancy loss and abnormal immunoprofiling.
排除标准
- •Female Participant having any endometrial disorder Known immunological diseases like Psoriasis,SLE, and RA etc.
- •Known case of congenital/acquired thrombophilia.
- •Uncorrected septate uterus, myoma and adenomyoma Thin endometrium less than 7mm despite measures to improve.
结局指标
主要结局
Ongoing Pregnancy rate
时间窗: 12 Weeks of pregnancy
次要结局
- clinical pregnancy rate(6 weeks of gestation)
研究者
Aruna R
A4 Hospital and Fertility centre