Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05918718 |
| Other study ID # |
IR.TUMS.IKHC.REC.1401.093 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2023 |
| Est. completion date |
December 20, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Tehran University of Medical Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
