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

NCT06504082 | Completed DMC

• 1 other identifier: YuzuncuYıl_MTX_LTZ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

methotrexate; letrozole

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Need of surgical interventions

  On the days of admission.

• Hospitalization Days

  Through study completion, an average of 3 weeks

Study Arms (2)

Letrozole + Single-Dose Methotrexate Group

ACTIVE COMPARATOR

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

Single-Dose Methotrexate

ACTIVE COMPARATOR

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

Interventions

Letrozole 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.

Letrozole + Single-Dose Methotrexate Group

Methotrexate 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

Single-Dose Methotrexate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Ectopic pregnancy patients are included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yuzuncu Yil University

Van, Tuşba, 06145, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Letrozole; Methotrexate

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 16, 2024
• Study Start: September 20, 2021
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2022
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)