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

Zagazig University

Status: Completed

Conditions: Pregnancy Tubal

Treatments: Drug: Letrozole; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT06426979

ZU-IRB#254 24/3-2024

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 22 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Group LTZ-MTX

Active Comparator group

Description:

Letrozole and Methotrexate Therapy's Group

Treatment:

Drug: Methotrexate

Drug: Letrozole

Group MTX

Active Comparator group

Description:

Methotrexate Therapy's Group

Treatment:

Drug: Methotrexate