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临床试验/CTRI/2025/08/092706
CTRI/2025/08/092706尚未招募3 期

to evaluate efficacy of an immunomodulator thymosin alpha 1 in women with previous IVF failure A Randomised controlled trial

wardha test tube baby centre1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
to evaluate efficacy of thymosin alpha 1 as an add on tretment to basic hormone therapy in frozen embryo transfer patients

研究概览

简要总结

A randomised controlled trial will be conducted to evaluate efficacy of immunomodulator thymosin alpha1 in patients with more than 1 previous IVF failure patients at wardha test tube baby centre at acharya vinoba bhave rural hospital ,datta meghe institute of higher education and research with inclusion criteria of patients giving informed consent to enroll in study aged 25 to 45 years old  with history of  more than1 previous  IVF failure and exclusion criteria will be patients with other systemic autoimmune disorders or any chromosomal abnormality

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • patients of IVF with previous 1 IVF failure with informed consent.

排除标准

  • known systemic autoimmune condition or known chromosomal abnormalities.

结局指标

主要结局

to evaluate efficacy of thymosin alpha 1 as an add on tretment to basic hormone therapy in frozen embryo transfer patients

时间窗: positive pregnancy outcome with urine pregnancy test at 4 weeks and ultrasonography at 6 weeks for fetal cardiac activity will be evaluated

次要结局

  • to evaluate changes in clinical pregnancy rates following thymosin alpha 1 administration(to check urine pregnacy positivity & ultrasonography at 6 weeks for clinical pregnancy positive rate with thymosin alpha 1 injections)

研究者

发起方
wardha test tube baby centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Deepika Dhundi

Datta Meghe institute of higher education and research

研究点 (1)

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