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临床试验/NCT01688284
NCT01688284终止不适用

The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage.

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
500
试验地点
1
主要终点
the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with RPL.

研究概览

简要总结

The aim of the study is to evaluate the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with Recurrent Pregnancy Losses (RPL).

详细描述

Office hysteroscopy examination of the patients at the luteal phase of the natural cycle (day17 to day 20),with endometrial biopsy using pipple curette from the region of the fundus, the biopsy sent to flow cytometry laboratory in South Egypt Cancer Institute to be examined for:

1.1. Phenotypic analysis of uterine natural killer cells:

1.2. Induction and detection of intracellular cytokines by flow Cytometry:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Women with unexplained recurrent miscarriages (2 or more consecutive).
  • •All patients have normal uterine cavity diagnosed by HSG and /or hysteroscopy, normal semen analysis, normal thrombophilic profiles, no history of malformed
  • •normal fetus in the previous miscarriages

排除标准

  • •Age above forty years old .
  • •Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
  • •Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  • •Fibroids distorting uterine cavity .
  • •Abnormal parental karyotype .
  • •Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

研究组 & 干预措施

No treatment

Active Comparator

patients with recurrent miscarriages

干预措施: office hysteroscopy (Device)

OFFICE HYSTEROSCOPY

Active Comparator

Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle

干预措施: office hysteroscopy (Device)

结局指标

主要结局

the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with RPL.

时间窗: two years

次要结局

  • to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure(two years)

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

alaa eldeen mahmoud ismail

Assistant professor ob/gyn,specialest of infertility and fetal medicine

Woman's Health University Hospital, Egypt

研究点 (1)

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