Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy
- Conditions
- Ectopic Pregnancy
- Interventions
- Registration Number
- NCT05918718
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- Pregnant women between 18-40 years of age who have spontaneously conceived and ectopic pregnancy has been definitively diagnosed.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description methotrexate methotrexate 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. Letrozole BD Letrozole 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. Letroozole TDS Letrozole 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.
- Primary Outcome Measures
Name Time Method Anti mulerian hormone 3 months βhCG on day 14
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Imam Khomeini Hospital Complex
🇮🇷Tehran, Iran, Islamic Republic of