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, and healthcare costs. This is a prospective study conducted on 60 ectopic pregnancy patients at Van Yuzuncu Yil University from June 2021 to September 2022. Thirty patients received single-dose methotrexate, while the other thirty received letrozole + single-dose methotrexate. Inclusion criteria were ß-hCG \<5000 mIU/mL, ectopic mass \<3-4 cm, no persistent abdominal pain, no fetal cardiac activity, and no contraindications to the treatments. Outcomes measured included treatment success, blood parameter changes, and the need for surgical intervention.

Detailed Description

Not available

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

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

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