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

NCT ID: NCT06504082

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2022-09-05

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.

Conditions

Ectopic Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Letrozole + Single-Dose Methotrexate Group

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.

Group Type: ACTIVE_COMPARATOR

Letrozole

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

After confirming the diagnosis of tubal ectopic pregnancy, each patient will receive a single dose of intramuscular MTX (50 mg/m² MTX) on the same day

Interventions

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.

Intervention Type: DRUG

Methotrexate

After confirming the diagnosis of tubal ectopic pregnancy, each patient will receive a single dose of intramuscular MTX (50 mg/m² MTX) on the same day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Metin Ayğar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yuzuncu Yil University

Van, Tuşba, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

YuzuncuYıl_MTX_LTZ

Identifier Type: -

Identifier Source: org_study_id