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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06426979
Enrollment
200
Registered
2024-05-23
Start date
2023-01-01
Completion date
2024-01-01
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Tubal

Brief summary

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.

Interventions

DRUGMethotrexate

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

DRUGLetrozole

FEMARA 2.5 mg tablets two tablets daily

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patients were divided into 2 Groups as the group titles were printed into cards that were enclosed in sealed envelopes and patients were asked to choose a closed envelop.

Eligibility

Sex/Gender
FEMALE
Age
22 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Rate of resolution of Tubal Ectopic Pregnancy (TEP)9 monthsRole of Letrozole in resolution of Tubal Ectopic Pregnancy (TEP) that was confirmed by TVU and without shifting to surgery.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026