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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-01

Brief Summary

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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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Detailed Description

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Conditions

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Pregnancy Tubal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Group LTZ-MTX

Letrozole and Methotrexate Therapy's Group

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

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

Letrozole

Intervention Type DRUG

FEMARA 2.5 mg tablets two tablets daily

Group MTX

Methotrexate Therapy's Group

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

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

Interventions

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Methotrexate

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

Intervention Type DRUG

Letrozole

FEMARA 2.5 mg tablets two tablets daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No