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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04308343
Other study ID # Aromatase inhibitor in ectopic
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 30, 2020
Est. completion date September 1, 2022

Study information

Verified date March 2020
Source Assiut University
Contact Ali Saber Ali, M.Sc
Phone 01095567589
Email kenous87@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date September 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Methotrexate
Drugs to treat undisturbed ectopic pregnancies
Letrozole
Drugs to treat undisturbed ectopic pregnancies
cetrotide
Drugs to treat undisturbed ectopic pregnancies

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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