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

Primary Purpose

Ectopic Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Methotrexate
Letrozole
cetrotide
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectopic Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Methotrexate group

    Letrozole group

    Gonadotropins releasing hormone antagonist group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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 .

    Secondary Outcome Measures

    Full Information

    First Posted
    March 9, 2020
    Last Updated
    March 11, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04308343
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 30, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2022 (Anticipated)
    Study Completion Date
    September 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to : Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate. Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ectopic Pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Methotrexate group
    Arm Type
    Active Comparator
    Arm Title
    Letrozole group
    Arm Type
    Active Comparator
    Arm Title
    Gonadotropins releasing hormone antagonist group
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Methotrexate
    Intervention Description
    Drugs to treat undisturbed ectopic pregnancies
    Intervention Type
    Drug
    Intervention Name(s)
    Letrozole
    Intervention Description
    Drugs to treat undisturbed ectopic pregnancies
    Intervention Type
    Drug
    Intervention Name(s)
    cetrotide
    Intervention Description
    Drugs to treat undisturbed ectopic pregnancies
    Primary Outcome Measure Information:
    Title
    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 .
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) . Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ali Saber Ali, M.Sc
    Phone
    01095567589
    Email
    kenous87@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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