Mifepristone and Letrozole versus methotrexate for treatment of Ectopic pregnancy - a randomized, controlled non-inferiority trial (MILE)

Conditions

Ectopic pregnancy

Brief summary

The primary endpoint is the proportion of patients who have a successful treatment response defined as decline of serum hCG to < 2 IU/L without the need for any additional medical or surgical intervention within 60 days of treatment.

Detailed description

The proportion of patients in both groups with adverse events (AE) and serious adverse events (SAE) classified as related or possibly related to treatment as judged by the investigators., The proportion of patients who need additional medical or surgical interventions in each group., Time to resolution (days) of ectopic pregnancy from start of medical treatment to resolution defined as hCG <2 IU/L., AMH-levels at baseline, 1 month and 3 months after treatment. We will also assess time to pregnancy (days) and pregnancy rates (%) within the first year after treatment., Micro RNAs (analyzed by single cell sequencing) profiles and CA-125 (patients receiving treatment for ectopic pregnancy versus patients with ultrasound confirmed intrauterine pregnancy within the same period of gestation)., Comparison of background factors between patients that have successful and unsuccessful treatment.

Related papers

No related papers found yet.

Interventions

DRUGlösning

DRUGMethotrexate Teva 100 mg/ml koncentrat till infusionsvätska

DRUGLetrozole Sandoz 2

DRUG5 mg filmdragerade tabletter

DRUGMifegyne 200 mg tabletter

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the proportion of patients who have a successful treatment response defined as decline of serum hCG to < 2 IU/L without the need for any additional medical or surgical intervention within 60 days of treatment.	—

Secondary

Measure	Time frame
The proportion of patients in both groups with adverse events (AE) and serious adverse events (SAE) classified as related or possibly related to treatment as judged by the investigators., The proportion of patients who need additional medical or surgical interventions in each group., Time to resolution (days) of ectopic pregnancy from start of medical treatment to resolution defined as hCG <2 IU/L., AMH-levels at baseline, 1 month and 3 months after treatment. We will also assess time to pregnancy (days) and pregnancy rates (%) within the first year after treatment., Micro RNAs (analyzed by single cell sequencing) profiles and CA-125 (patients receiving treatment for ectopic pregnancy versus patients with ultrasound confirmed intrauterine pregnancy within the same period of gestation)., Comparison of background factors between patients that have successful and unsuccessful treatment.	—

Measure

Time frame

The proportion of patients in both groups with adverse events (AE) and serious adverse events (SAE) classified as related or possibly related to treatment as judged by the investigators., The proportion of patients who need additional medical or surgical interventions in each group., Time to resolution (days) of ectopic pregnancy from start of medical treatment to resolution defined as hCG <2 IU/L., AMH-levels at baseline, 1 month and 3 months after treatment. We will also assess time to pregnancy (days) and pregnancy rates (%) within the first year after treatment., Micro RNAs (analyzed by single cell sequencing) profiles and CA-125 (patients receiving treatment for ectopic pregnancy versus patients with ultrasound confirmed intrauterine pregnancy within the same period of gestation)., Comparison of background factors between patients that have successful and unsuccessful treatment.

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Countries

Sweden

Outcome results

None listed