Investigation and comparison of antimullerin hormone in patients with EP, tubal ectopic pregnancy treated with methotrexate and laparoscopy
Design
A clinical trial with a control group, with parallel groups
Settings and conduct
50 patients are involved in this study. There are 25 patients in each group. The first group is treated with methotrexate at a dose of 1 mg/kg as a single dose. The second group is treated with laparoscopic surgery. It is done in Shariati Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adult women aged 18-40, patients who do not have any relative or absolute contraindications for using methotrexate, no liver failure, no chronic renal failure with GFR less than 30 mL/min, no Lung diseases, stomach ulcers and immune deficiencies. exclusion criteria: the patient's dissatisfaction with continuing to participate in the study, the occurrence of complications related to methotrexate in the group treated with methotrexate.
Intervention groups
The first group is treated with methotrexate at a dose of 1 mg/kg as a single dose. The second group is treated with laparoscopic surgery.
Main outcome variables
Evaluation of the level of antimullerin hormone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240514061800N4
Registration date:2024-08-21, 1403/05/31
Registration timing:prospective
Last update:2024-08-21, 1403/05/31
Update count:0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
shahedeh khansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4643 2157
Email address
b_sh2110@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of antimullerin hormone in patients with tubal ectopic pregnancy treated with methotrexate and laparoscopy.
Public title
Investigation and comparison of antimullerin hormone in patients with tubal ectopic pregnancy treated with methotrexate and laparoscopy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult women 18-40 years old
Patients who do not have any relative or absolute contraindications for using methotrexate
Absence of liver failure
Not suffering from chronic renal failure with GFR less than 30 mL/min
No lung diseases, stomach ulcers and immune deficiencies
Exclusion criteria:
The patient's lack of consent to continue participating in the study
Incidence of complications related to methotrexate in the group treated with methotrexate
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2023-09-18, 1402/06/27
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1402.098
Health conditions studied
1
Description of health condition studied
Ectopic Pregnancy
ICD-10 code
O00
ICD-10 code description
Ectopic pregnancy
Primary outcomes
1
Description
Evaluation of the level of antimullerin hormone
Timepoint
Before, 3 and 6 months after the intervention
Method of measurement
Biochemical tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are treated with methotrexate at a dose of 1 mg/kg as a single dose.