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临床试验/NCT03452735
NCT03452735Unknown不适用

Fertility Study of Women With Chronic Inflammatory Rheumatism

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 2,900 人开始时间: 2018年7月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,900
试验地点
1
主要终点
Birth rate after spontaneous or induced pregnancy

研究概览

简要总结

Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and environmental factors. Their impact on the quality of life is important, leading to a sometimes severe disability. Thus they are likely to affect female fertility through several mechanisms, including autoimmune since the association between immunity and fertility has already been demonstrated in other autoimmune diseases.

This study wants to evaluate and compare the birth rate between CIR and control group.

详细描述

Data collection will be carried out using a questionnaire submitted to women in charge of the rheumatology department of the University Hospital of Toulouse and having agreed to participate:

  • women with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis or Chronic juvenile arthritis for the chronic inflammatory rheumatism group
  • women with a mechanical rheumatic pathology for the control group

The primary endpoint was birth rate after spontaneous or induced pregnancy in patients who attempted to procreate, in the CIR group and in the control group.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism
  • Patient diagnosed before the age of 40
  • Patient having given her no opposition to her participation in research
  • For the control group: patient not suffering from chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology

排除标准

  • Patient> 40 years old at the time of diagnosis
  • Patient with insufficient medical data (treatments)

结局指标

主要结局

Birth rate after spontaneous or induced pregnancy

时间窗: One day

Birth rate after spontaneous or induced pregnancy in women who have tried to procreate in the chronic inflammatory rheumatism group and in the control group.

次要结局

  • Rates of ectopic pregnancy, early or late spontaneous miscarriage(one day)
  • Rates of desire for pregnancy(One day)
  • Design time(One day)
  • Birth rate according to the treatments used(One day)
  • Birth rate according to the activity of the disease(One day)
  • Rates of sexual dysfunction(One day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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