Investigation of the effect of letrozole in the treatment of ectopic pregnancies compared to methotrexate.

Phase 2

Recruiting

• Conditions: Ectopic pregnancy..; Ectopic pregnancy, unspecified; O00.9

• Registration Number: IRCT20170828035961N2
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Proven ectopic pregnancy(EP)
Patient age 18-40 years
Serum level (BHCG) beta Human Chorionic Gonadotropin less than 5000
Serum hemoglobin level above 10
Serum platelet level above 150,000

Exclusion Criteria

unstability of vital signs and occurrence of symptoms related to internal bleeding.
The presence of surgical indications (viewing the fetal heart, abdominal EP(ectopic pregnancy), size above 3.5 cm, EP rupture and abdominal bleeding)
Contraindications for use of letrozole or methotrexate (chronic kidney, liver and blood diseases, immunodeficiency, breastfeeding, active lung disease, peptic ulcer, simultaneous intrauterine pregnancy, drug interactions, severe drug sensitivity)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of beta Human Chorionic Gonadotropin(BHCG). Timepoint: The first day of treatment and days 4, 7 and 14 after treatment. Method of measurement: BHCG test.

Secondary Outcome Measures

Name	Time	Method
Serum levels of liver enzymes. Timepoint: The first day of treatment and 7 days after that. Method of measurement: Blood test.;Serum levels of creatinine. Timepoint: The first day of treatment and 7 days after that. Method of measurement: Blood test.;Serum hemoglobin level. Timepoint: The first day of treatment and 7 days after that. Method of measurement: Blood test.;Counting the number of blood platelets. Timepoint: The first day of treatment and 7 days after that. Method of measurement: Blood test.;Anti-Müllerian hormone serum level. Timepoint: The first day of treatment and 3 months after that. Method of measurement: Blood test.;Drug side effects. Timepoint: while taking medication. Method of measurement: check list.;History of ectopic pregnancy. Timepoint: The beginning of treatment. Method of measurement: check list.;Number of pregnancies. Timepoint: The beginning of treatment. Method of measurement: check list.