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
About this trial
This is an interventional treatment trial for Ectopic Pregnancy
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
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
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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