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

NCT04308343 | Unknown

• 1 other identifier: Aromatase inhibitor in ectopic
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to :

1. 1.Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate.
2. 2.Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (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

Study Arms (3)

Methotrexate group

ACTIVE COMPARATOR

Drug: Methotrexate

Letrozole group

ACTIVE COMPARATOR

Drug: Letrozole

Gonadotropins releasing hormone antagonist group

ACTIVE COMPARATOR

Drug: cetrotide

Interventions

Methotrexate DRUG

Drugs to treat undisturbed ectopic pregnancies

Methotrexate group

Letrozole DRUG

Drugs to treat undisturbed ectopic pregnancies

Letrozole group

cetrotide DRUG

Drugs to treat undisturbed ectopic pregnancies

Gonadotropins releasing hormone antagonist group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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) .

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate; Letrozole; cetrorelix

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Ali Saber Ali, M.Sc

CONTACT

01095567589; kenous87@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 16, 2020
• Study Start: March 30, 2020
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share