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

NCT ID: NCT04308343

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ectopic Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Methotrexate group

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

Drugs to treat undisturbed ectopic pregnancies

Letrozole group

Group Type ACTIVE_COMPARATOR

Letrozole

Intervention Type DRUG

Drugs to treat undisturbed ectopic pregnancies

Gonadotropins releasing hormone antagonist group

Group Type ACTIVE_COMPARATOR

cetrotide

Intervention Type DRUG

Drugs to treat undisturbed ectopic pregnancies

Interventions

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Methotrexate

Drugs to treat undisturbed ectopic pregnancies

Intervention Type DRUG

Letrozole

Drugs to treat undisturbed ectopic pregnancies

Intervention Type DRUG

cetrotide

Drugs to treat undisturbed ectopic pregnancies

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali saber ali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ali Saber Ali, M.Sc

Role: CONTACT

01095567589

Other Identifiers

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Aromatase inhibitor in ectopic

Identifier Type: -

Identifier Source: org_study_id

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