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

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04308343
• Collaborator: (none)
• Enrollment: 120
• Arms: 3
• Anticipated Duration (Months): 29.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ectopic Pregnancy	Drug: Methotrexate; Drug: Letrozole; Drug: cetrotide	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
• Anticipated Study Start Date: Mar 30, 2020
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ali saber ali, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04308343
• Other Study ID Numbers: Aromatase inhibitor in ectopic
• First Posted: Mar 16, 2020
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature; Methotrexate; Letrozole; Cetrorelix

Study Results

No Results Posted as of Mar 16, 2020