跳至主要内容
临床试验/NCT04943146
NCT04943146Unknown不适用

An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity Undergoing In Vitro Fertilization

Second Affiliated Hospital, School of Medicine, Zhejiang University2 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
402
试验地点
2
主要终点
clinical pregnancy rate

研究概览

简要总结

Thyroid autoimmunity(TAI) per se have adverse effect on pregnancy outcomes,and aspirin and prednisone were used frequently in antithyroid antibodies(ATA) positive infertile women in clinical practice, but the impact of these medicines is still controversial. Therefore, aim of the study was to investigate whether or not the treatment of prednisone in addition to aspirin was capable of improving reproductive outcomes in euthyroid infertile women.

详细描述

A multicenter retrospective study performed during the period of 2017 to 2020 and euthyroid infertile women positive for anti-thyroperoxidase antibody (TPOAb) and/or thyroglobulin antibody (TgAb) alone with thyroid stimulating hormone 0.35-4.0mIU/L undergoing first in vitro fertilization and embryo transfer(IVF-ET) cycle were recruited in our study.Data analysis was performed using the Statistics Package for Social Sciences.In the end, the value of prednisone plus aspirin treatment was investigated to make a big contribution on clinical practice.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Both TPOAb and TgAb in all the subjects were measured before ART procedure
  • Thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L
  • Women underwent first embryo transfer without previous IVF history.

排除标准

  • Abnormal thyroid function test
  • Women with known autoimmune diseases or clinical presentations of autoimmune disorders

研究组 & 干预措施

P+A group

aspirin: tablet 100mg qd 2-5weeks prednisone: tablet 10mg qd 2-5weeks

干预措施: Prednisone 10 MG+aspirin 100MG (Drug)

结局指标

主要结局

clinical pregnancy rate

时间窗: 3 mouths

Clinical pregnancy was defined as the existence of a viable embryo within an intrauterine gestational sac

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验