Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2020-12-01
2023-06-30
Brief Summary
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Detailed Description
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Two study arms were planned:
i) women treated with MTX: MTX in a single dose of 100 mg intravenously on day 0; ii) women treated with letrozole: letrozole at a daily dose of 5 mg orally for 10 days from day 0.
The inclusion criteria included B-hCG concentration up to 3000 mIU/ml and no contraindications to conservative treatment. Women who did not meet criteria for conservative treatment were excluded. Blood parameters (B-hCG, hemoglobin, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7. Cases of treatment failure were counted, i.e. the need to perform laparoscopy due to tubal pregnancy rupture, pain, increase in B-hCG concentration.
The women were given the option to choose the treatment used in the study. All enrolled women gave informed written consent to participate in the study.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tubal pregnancy treated with MTX
MTX in a single dose of 100 mg intravenously on day 0
MTX as monotherapy
MTX in a single dose of 100 mg intravenously on day 0
Tubal pregnancy treated with letrozole
Letrozole in a daily dose of 5 mg (2 x 2.5 mg) orally for 10 days from day 0
Letrozole as monotherapy
Letrozole 5 mg daily orally for 10 days from day 0
Interventions
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Letrozole as monotherapy
Letrozole 5 mg daily orally for 10 days from day 0
MTX as monotherapy
MTX in a single dose of 100 mg intravenously on day 0
Eligibility Criteria
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Inclusion Criteria
* increasing serum B-hCG concentrations in at least two subsequent measures
* serum B-hCG concentration ≤ 3000 mIU/ml
Exclusion Criteria
* positive fetal heartbeat on pelvic ultrasound
* abdominal pain
* heterotopic pregnancy
* contraindications to MTX
18 Years
45 Years
FEMALE
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Iwona Magdalena Gawron
M.D., Ph.D., Principal Investigator
Principal Investigators
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Robert Jach, Prof., Ph.D.
Role: STUDY_CHAIR
Jagiellonian University
Locations
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Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology
Krakow, , Poland
Countries
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Other Identifiers
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1072.6120.321.2020
Identifier Type: -
Identifier Source: org_study_id
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