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临床试验/NCT04308343
NCT04308343Unknown不适用

The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

Assiut University0 个研究点目标入组 120 人开始时间: 2020年3月30日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
120
主要终点
determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated .
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of this study is to :

  1. Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate.
  2. Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •Patients who have undisturbed ectopic pregnancy .Who are:
  • •have no significant pain
  • •have an unruptured tubal ectopic pregnancy with an adnexal mass smaller than 35mm with no visible heartbeat
  • •have a serum human chorionic gonadotropins level less than 1,500 IU/litre
  • •do not have an intrauterine pregnancy (as confirmed on an ultrasound scan) .

排除标准

  • •An undisturbed ectopic pregnancy and significant pain
  • •An undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger
  • •An undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan
  • •An undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of 5,000 IU/litre or more
  • •intrauterine pregnancy

研究组 & 干预措施

Methotrexate group

Active Comparator

干预措施: Methotrexate (Drug)

Letrozole group

Active Comparator

干预措施: Letrozole (Drug)

Gonadotropins releasing hormone antagonist group

Active Comparator

干预措施: cetrotide (Drug)

结局指标

主要结局

determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated .

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali saber ali

Principal Investigator

Assiut University

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