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

Yuzuncu Yıl University

Status: Completed

Conditions: Ectopic Pregnancy

Treatments: Drug: Letrozole; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT06504082

YuzuncuYıl_MTX_LTZ

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Letrozole + Single-Dose Methotrexate Group

Active Comparator group

Description:

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.

Treatment:

Drug: Letrozole

Single-Dose Methotrexate

Active Comparator group

Description:

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.

Treatment:

Drug: Methotrexate