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