Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy

Not Applicable

Completed

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

• Registration Number: NCT06504082
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and reduction of maternal morbidity, mortality, a...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-03-14
• Study Completion: 2023-06-01
• Study First Submitted: 2024-06-30
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-13
• Last Update Submitted: 2024-07-13
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Patients diagnosed with ectopic pregnancy according to the diagnostic criteria
• Patients with β-hCG levels <5000 mIU/ml,
• Patients without serious or persistent abdominal pain
• Patients without fetal cardiac activity observed
• Ectopic mass size smaller than 3-4 cm
• Patients without contraindications for methotrexate and letrozole

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Exclusion Criteria

• Ruptured ectopic pregnancies
• Hemodynamically unstable patients
• Patients with acute abdomen or intra-abdominal bleeding
• Patients with fetal cardiac activity
• β-hCG levels below 500 mIU/mL or above 5000 mIU/mL
• Patients non-compliant with treatment
• Ectopic pregnancy size over 40 mm

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole + Single-Dose Methotrexate Group	Letrozole	Patients in the MTX + letrozole group received letrozole tablets (Femara 2.5 mg) once daily for ten days starting from the day of MTX administration.
Single-Dose Methotrexate	Methotrexate	After confirming the diagnosis of tubal ectopic pregnancy, each patient received a single dose of intramuscular MTX (50 mg/m² MTX) on the same day.

Primary Outcome Measures

Name	Time	Method
Decrease in β-hCG levels	On day 1, 4 and 7	Serum β-hCG titration was monitored on days 1, 4, and 7 using the same laboratory kit.

Secondary Outcome Measures

Name	Time	Method
Hospitalization Days	Through study completion, an average of 3 weeks
Need of surgical interventions	On the days of admission.

Trial Locations

Locations (1)

Yuzuncu Yil University; 🇹🇷 Van, Tuşba, Turkey