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临床试验/NCT03174951
NCT03174951已完成2 期

Effect of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss With Immunological Causes

Tabriz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年9月20日最近更新:
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
50
试验地点
1
主要终点
Changes in NK cells, T reg and Th17 cells frequency.

研究概览

简要总结

Miscarriage occurs in about 1-2% of human pregnancies and is one of the common pregnancy problems before 12 weeks of pregnancy. Anatomical and chromosomal abnormalities, microbial factors and auto and alloimmune reactions have been speculated to attribute in recurrent miscarriage. Unexplained recurrent miscarriage (URM) is defined as three or more repeated abortions, probably caused by maternal immunological rejection . Given that maternal immune system encounters semi-allogeneic fetus, pregnancy outcome is associated with the interaction between maternal immune system and immuno-regulatory capability of the fetus. Effectiveness of treatment approaches in RM patients has been controversial and remained to be discovered. Immunomodulatory agents such as corticosteroids and allogeneic lymphocyte immunization showed variable success rates in RM patients. Therapeutic effects of IVIG in unexplained RM is controversial and most positive results were obtained from the trials in RM women with cellular immune abnormalities, such as increased NK cell level and/or cytotoxicity, and T cell abnormalities. Previous studies have shown that the incidence of genetic abnormalities in children who have received immunosuppressive drugs such as IVIg like normal people and normal society. In this study we used IVIg at the time of positive pregnancy,400 mg/kg IVIG was administered intravenously. Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation to suppress the immune system in patients with immunological causes of RPL and the results will be compared with a control group that did not receive any type of drug.

研究设计

研究类型
Interventional
分配方式
Non 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 41 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Enrolled patients will experience at least 3 times recurrent pregnancy loss.
  • Patients dont have history of any type of immunotherapy.
  • Patients must have abnormal NK cell or NK cell cytotoxicity or Th1/Th2 ratio

排除标准

  • Our criteria for exclusion of patients from the study include the following:
  • Patients or their spouse has abnormal karyotype or chromosomal and genetically disorders.
  • Patients who have bleeding problems.
  • Patients who have chronic disorders those are forced to use the specific drug.
  • Patients who have positive test for HIV, HCV or HBV infection.
  • Patients who have a history of asthma and allergies.
  • Patients who have uterus abnormalities.

研究组 & 干预措施

Treatment group

Experimental

IVIg group

干预措施: IVIg (Drug)

结局指标

主要结局

Changes in NK cells, T reg and Th17 cells frequency.

时间窗: up to 8 month of pregnancy

Flowcytometry

Changes in exoression of cytokines gene.

时间窗: up to 8 month of pregnancy

RT pcr

Changes in secretion levels of cytokines related to Treg and Th17 cells(IL-17,IL-21)

时间窗: up to 8 month of pregnancy

Elisa

次要结局

  • Live berth rate in patients with Recurrent Pregnancy Loss (RPL).(up to 1 year)
  • Ongoing pregnancy rate in patients with Recurrent Pregnancy Loss (RPL)(up to 8 month of pregnancy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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