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

Not Applicable

• Conditions: Ectopic Pregnancy
• Interventions: Drug: cetrotide; Drug: Letrozole; Drug: Methotrexate

• Registration Number: NCT04308343
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Study First Posted: 2020-03-16
• Last Update Posted: 2020-03-16
• Study Start: 2020-03-30
• Primary Completion: 2022-03-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gonadotropins releasing hormone antagonist group	cetrotide	-
Letrozole group	Letrozole	-
Methotrexate group	Methotrexate	-

Primary Outcome Measures

Name	Time	Method
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 .	3 months