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

March 11, 2020 updated by: Ali saber ali, Assiut University

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methotrexate group
Drug: Methotrexate
Drugs to treat undisturbed ectopic pregnancies
Active Comparator: Letrozole group
Drug: Letrozole
Drugs to treat undisturbed ectopic pregnancies
Active Comparator: Gonadotropins releasing hormone antagonist group
Drug: cetrotide
Drugs to treat undisturbed ectopic pregnancies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 30, 2020

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aromatase inhibitor in ectopic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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