Sequential Letrozole and Methotrexate Therapy Role in 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.

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Key information

Conditions

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

Age range

22 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university

Zagazig, Ash Sharqia Governorate, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

methotrexate

Drug

Methotrexate 25 mg/ml was given as single-dose of intramuscular (IM) injection in a dose of 50 mg/m2.

letrozole

Drug

FEMARA 2.5 mg tablets two tablets daily

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: May 23, 2024
Registry last updated: May 28, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed