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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    



Study Type

Interventional


Primary Outcome

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 .


Condition

Ectopic Pregnancy

Intervention

Methotrexate

Study Arms / Comparison Groups

 Methotrexate group
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

March 30, 2020

Completion Date

September 1, 2022

Primary Completion Date

March 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who have undisturbed ectopic pregnancy .Who are:

               1. have no significant pain

               2. have an unruptured tubal ectopic pregnancy with an adnexal mass smaller than 35mm
                  with no visible heartbeat

               3. have a serum human chorionic gonadotropins level less than 1,500 IU/litre

               4. do not have an intrauterine pregnancy (as confirmed on an ultrasound scan) .

        Exclusion Criteria:

          1. An undisturbed ectopic pregnancy and significant pain

          2. An undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger

          3. An undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan

          4. An undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of
             5,000 IU/litre or more

          5. intrauterine pregnancy
      

Gender

Female

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

No

Contacts

, 01095567589, [email protected]



Administrative Informations


NCT ID

NCT04308343

Organization ID

Aromatase inhibitor in ectopic


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

, , 


Verification Date

March 2020