Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy

May 23, 2024 updated by: Walid Mohamed Elnagar, Zagazig University

Sequential Letrozole and Methotrexate Therapy Safely Improved the Outcomes of Medical Treatment of Tubal Ectopic Pregnancy

Ectopic pregnancy (EP) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. Tubal EP (TEP) is the most common and poses a significant risk to maternal life. Early diagnosis and medical treatment, such as methotrexate (MTX) and the Fallopian tube (FT), have been studied. However, the efficacy of single-dose methotrexate (SD-MTX) is questionable, and the efficacy of two-dose versus SD-MTX for medical management of EP is being evaluated. High estrogens/progesterone ratios can disrupt embryonic motility and lead to TEP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Ash Sharqia Governorate
      • Zagazig, Ash Sharqia Governorate, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presence of gestational masses of <3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity;
  • Absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on TVU and pre-treatment serum hCG of <3500 IU/L.

Exclusion Criteria:

  • Free of Inclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group LTZ-MTX
Letrozole and Methotrexate Therapy's Group
Drug: Methotrexate
Methotrexate 25 mg/ml was given as single-dose of intramuscular (IM) injection in a dose of 50 mg/m2.
Drug: Letrozole
FEMARA 2.5 mg tablets two tablets daily
Active Comparator: Group MTX
Methotrexate Therapy's Group
Drug: Methotrexate
Methotrexate 25 mg/ml was given as single-dose of intramuscular (IM) injection in a dose of 50 mg/m2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Rate of resolution of Tubal Ectopic Pregnancy (TEP)
Time Frame: 9 months
Role of Letrozole in resolution of Tubal Ectopic Pregnancy (TEP) that was confirmed by TVU and without shifting to surgery.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB#254 24/3-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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