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Completed

NCT Number: NCT06504082

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.

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Key information

Conditions

Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yuzuncu Yil University

Van, Tuşba, 06145, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Decrease in β-hCG levels

    Time frame: On day 1, 4 and 7

    Serum β-hCG titration was monitored on days 1, 4, and 7 using the same laboratory kit.

Secondary outcomes

  1. Need of surgical interventions

    Time frame: On the days of admission.

  2. Hospitalization Days

    Time frame: Through study completion, an average of 3 weeks

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2024
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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