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

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.

Study Overview

• Status: Completed
• Conditions: Ectopic Pregnancy
• Intervention / Treatment: Drug: Letrozole; Drug: Methotrexate

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tuşba
    • Van, Tuşba, Turkey, 06145
      • Yuzuncu Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): September 5, 2022
• Study Completion (Actual): September 5, 2022

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: methotrexate; letrozole
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Pregnancy Complications; Arrhythmias, Cardiac; Pregnancy, Ectopic; Cardiac Complexes, Premature; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Antirheumatic Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Antimetabolites, Antineoplastic; Antimetabolites; Dermatologic Agents; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Estrogen Antagonists; Aromatase Inhibitors; Letrozole; Methotrexate
• Other Study ID Numbers: YuzuncuYıl_MTX_LTZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared directly upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No