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CompletedNCT06504082Updated Jul 25, 2025

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

An interventional study of Letrozole and Methotrexate in Ectopic Pregnancy, sponsored by Yuzuncu Yil University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by Yuzuncu Yil University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Sep 2021, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Ectopic Pregnancy

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Keywords

  • methotrexate
  • letrozole
03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

Yuzuncu Yil University is the lead sponsor of 78 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for methotrexate and letrozole

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • 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.

  • 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

06

What researchers measure

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.

    Time frame: On day 1, 4 and 7

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

07

Study locations

1 site
  • Yuzuncu Yil University
    Van, Tuşba 06145, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — IPD will be shared directly upon reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06504082
Lead sponsor
Yuzuncu Yil University
Responsible party
Metin Ayğar (Principal Investigator, Yuzuncu Yil University) — Principal investigator
First posted
Jul 16, 2024
Start date
Sep 20, 2021
Primary completion
Sep 5, 2022
Completion
Sep 5, 2022
Last update
Jul 25, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Letrozole · Methotrexate

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