Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy

Tehran University of Medical Sciences

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Ectopic Pregnancy

Treatments: Drug: methotrexate; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT05918718

IR.TUMS.IKHC.REC.1401.093

Details and patient eligibility

About

In this study, about 150 women diagnosed with ectopic pregnancy who are referred to the Obstetrics and Gynecology Center of Valiasr Hospital are included in the study. Demographic information including both gynecological and obstetrical data is collected. Ectopic ectopic pregnancy is confirmed by transvaginal ultrasound. The patients are randomly allocated to three groups The first group will receive a single dose of methotrexate The second group will receive letrozole within a 10-day period, twice a day The third group will receive letrozole in a 5-day period three times a day In the first group, the first day of drug injection is counted, and the drug is measured at a dose of 50 mg/m2 and divided intramuscularly. The hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.

In the second group, letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.

In the third group, letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.

Also, the level of blood cells, liver enzymes, urea level and serum creatinine level are measured on the first day and the seventh day after the treatment.

The level of antimullerin hormone is measured on the first day and 3 months after the treatment.

Full description

In this study, about 150 women diagnosed with ectopic pregnancy who are referred to the Obstetrics and Gynecology Center of Valiasr Hospital are included in the study. Demographic information including both gynecological and obstetrical data is collected. Ectopic ectopic pregnancy is confirmed by transvaginal ultrasound. The patients are randomly allocated to three groups The first group will receive a single dose of methotrexate The second group will receive letrozole within a 10-day period, twice a day The third group will receive letrozole in a 5-day period three times a day In the first group, the first day of drug injection is counted, and the drug is measured at a dose of 50 mg/m2 and divided intramuscularly. The hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.

In the second group, letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.

In the third group, letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.

Also, the level of blood cells, liver enzymes, urea level and serum creatinine level are measured on the first day and the seventh day after the treatment.

The level of antimullerin hormone is measured on the first day and 3 months after the treatment.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women between 18-40 years of age who have spontaneously conceived and ectopic pregnancy has been definitively diagnosed.

Exclusion criteria

• B-HCG levels more or equal to 5000
• Hemoglobin level less than 10 g/dl Platelet level less than 100,000
• Increasing the level of liver function tests and the level of urea and creatinine The presence of fetal heart activity in the gestational sac

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

methotrexate

Experimental group

Description:

The first group will receive a single dose (50 mg/m2) of methotrexate The beta-hcg level is measured on the first day, and the hcg serum level is routinely measured on the fourth, seventh and fourteenth day.

Treatment:

Drug: methotrexate

Letrozole BD

Experimental group

Description:

The first group will receive letrozole is given in the form of 2.5 mg tablets twice a day for 10 days. And on the fourth, seventh and fourteenth day, the HCG level is measured.

Treatment:

Drug: Letrozole

Letroozole TDS

Experimental group

Description:

letrozole is given in the form of 2.5 mg tablets 3 times a day for 5 days, and hCG levels are measured on days 4, 7, and 14.

Treatment:

Drug: Letrozole