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Sequential vs. Combined Letrozole and Methotrexate for Tubal Ectopic Pregnancy.
Sponsor: Benha University
Summary
This study evaluates two medical strategies designed to minimize surgical intervention and reduce methotrexate (MTX) exposure in women with undisturbed tubal ectopic pregnancy (TEP). Participants with undisturbed TEP and pre-treatment serum $\\beta$-hCG levels $\<3500\\text{ IU/L}$ are randomized to receive either a sequential regimen (initial letrozole monotherapy, reserving MTX only for treatment non-responders) or a combined regimen (simultaneous letrozole and single-dose MTX from day one). The study aims to compare the overall success rate of resolving TEP without emergency surgery, as well as the ability of the sequential approach to avoid MTX administration altogether.
Official title: Minimizing Surgical Intervention in Tubal Ectopic Pregnancy: A Randomized Comparison Between Sequential and Combined Letrozole and Single-Dose Methotrexate Regimens.
Key Details
Gender
FEMALE
Age Range
24 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2024-12-15
Completion Date
2026-12-12
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
Letrozole
Oral Letrozole 5 mg/day (2 times 2.5{ mg} tablets daily) for 4 days. If serum beta-hCG drops by \>10% on Day 4, Letrozole is continued.
Methotrexate
A single intramuscular injection of Methotrexate (50mg/m) is administered as rescue therapy, If beta-hCG drop is \<10 on Day 4,
Locations (1)
Benha university
Banhā, El Qalyoubia, Egypt