Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 19, 2024
CompletedFirst Posted
Study publicly available on registry
May 23, 2024
CompletedMay 28, 2024
May 1, 2024
5 months
May 19, 2024
May 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The Rate of resolution of Tubal Ectopic Pregnancy (TEP)
Role of Letrozole in resolution of Tubal Ectopic Pregnancy (TEP) that was confirmed by TVU and without shifting to surgery.
9 months
Study Arms (2)
Group LTZ-MTX
ACTIVE COMPARATORLetrozole and Methotrexate Therapy's Group
Group MTX
ACTIVE COMPARATORMethotrexate Therapy's Group
Interventions
Methotrexate 25 mg/ml was given as single-dose of intramuscular (IM) injection in a dose of 50 mg/m2.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig university
Zagazig, Ash Sharqia Governorate, 44519, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of Gynecology
Study Record Dates
First Submitted
May 19, 2024
First Posted
May 23, 2024
Study Start
January 1, 2023
Primary Completion
June 1, 2023
Study Completion
January 1, 2024
Last Updated
May 28, 2024
Record last verified: 2024-05