The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

Assiut University

Status: Unknown

Conditions: Ectopic Pregnancy

Treatments: Drug: cetrotide; Drug: Letrozole; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT04308343

Aromatase inhibitor in ectopic

Details and patient eligibility

About

The aim of this study is to :

1. Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate.
2. Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have undisturbed ectopic pregnancy .Who are:

  1. have no significant pain
  2. have an unruptured tubal ectopic pregnancy with an adnexal mass smaller than 35mm with no visible heartbeat
  3. have a serum human chorionic gonadotropins level less than 1,500 IU/litre
  4. do not have an intrauterine pregnancy (as confirmed on an ultrasound scan) .

Exclusion criteria

1. An undisturbed ectopic pregnancy and significant pain
2. An undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger
3. An undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan
4. An undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of 5,000 IU/litre or more
5. intrauterine pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Methotrexate group

Active Comparator group

Treatment:

Drug: Methotrexate

Letrozole group

Active Comparator group

Treatment:

Drug: Letrozole

Gonadotropins releasing hormone antagonist group

Active Comparator group

Treatment:

Drug: cetrotide