Letrozole in Tubal Ectopic Pregnancy

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

Tubal ectopic pregnancies are abnormal pregnancies in the Fallopian tube, rather than in the womb. They occurred in around 1-2% of all pregnancies. Methotrexate (MTX) given by the intramuscular route i.e. systemic, a commonly used drug for cancer , was a widely used alternative for management for unruptured tubal ectopic pregnancies and was recommended as first line treatment for selected women.

Letrozole, aromatase inhibitor, can suppose oestradiol level. Combination of letrozole with misprostol has shown to improve the complete abortion rate in miscarriage. As a result, addition of letrozole may cause a higher success rate in the medical treatment of ectopic pregnancy.

As the evidence of combination of MTX and letrozole in tubal ectopic pregnancies is not available, the objective of the present study is to evaluate efficacy of combination of MTX and letrozole in women with tubal ectopic pregnancies

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen Mary Hospital, Hong Kong
• Treatments: Letrozole

Criteria

Inclusion Criteria:

• Tubal ectopic pregnancy suggested by presence of a heterogenous adnexal mass with suboptimal rise of hCG i.e. <= 63% rise over 48 hours

• hCG level <= 5000 IU/l

• Absence of fetal heart pulsation

• Mean diameter of adnexal mass <= 3.5cm

• Haemodynamically stable

• No significant abdominal pain

Exclusion Criteria:

• Presence of significant amount of free fluid in pelvis

• Allergic to MTX

• Deranged liver function test (AST/ ALT or GGT >= 2 upper limit of normal)

• Deranged renal function test (eGFR <= 45ml/min)

• Heterotopic pregnancies