Comparison of diagnostic accuracy "three-dimensional transvaginal sonography ", "three-dimensional transvaginal sonography with saline infusion and laparoscopy Hysteroscopy"in diagnosis of septated and bicornuate uterus uterine.
The aim of this study is Comparison of diagnostic accuracy "three-dimensional transvaginal sonography ", "three-dimensional transvaginal sonography with saline infusion and laparoscopy Hysteroscopy"in diagnosis of uterine anomalies.
This study is prospective interventional.
We enrolled 120 child bearing age women with septated or bicornuate uterus by histerosalpingography and obstetric history of miscarriage or candidate for IVF-ICSI .Three-dimensional transvaginal sonography "and "three-dimensional transvaginal sonography with saline infusion was performed for all patients and regard less of the results of three-dimensional transvaginal sonography "and "three-dimensional transvaginal sonography with saline, laparoscopy Hysteroscopy operation was done for all patients then diagnostic results of uterine anomaly by Three-dimensional transvaginal sonography "and "three-dimensional transvaginal sonography with saline and laparoscopy Hysteroscopy operation was compered and diagnostic accuracy of uterine anomaly by"three-dimensional transvaginal sonography "and "three-dimensional transvaginal sonography with saline infusion" and laparoscopy Hysteroscopy operatin was compered.Inclusion criteria were as follow:
1-Child bearing age women with septated or bicornuate uterus by histerosalpingography; 2- obstetric history of miscarriage or candidate for IVF-ICSI.
This patients excluded from study:
1-18≤patient age≥45; 2-No desire for conception; 3-pregnancy; 4-uterine or cervical malignanc; 5-cervicities,vaginities and recent history of PID.
Interventions included: Three-dimensional transvaginal sonography "and "three-dimensional transvaginal sonography with saline infusion.Main outcome of study is Comparison of diagnosis of uterine anomaly by three-dimensional transvaginal sonography , three-dimensional transvaginal sonography with saline infusion and laparoscopy Hysteroscopy operation.Interventions included:1-Diagnosis of uterine anomaly by three-dimensional transvaginal sonography 2- Diagnosis of uterine anomaly by three-dimensional transvaginal sonography with saline infusion 3-Diagnosis of uterine anomaly by laparoscopy Hysteroscopy operation 4-BMI 5-Prior history of infertility 6-age 7-prior history of abortion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041733490N1
Registration date:2017-07-03, 1396/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-03, 1396/04/12
Registrant information
Name
Zahra Dehbashi
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8608 9076
Email address
zdehbashi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences,Vice chancellor for research
Expected recruitment start date
2017-05-16, 1396/02/26
Expected recruitment end date
2018-03-17, 1396/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of diagnostic accuracy "three-dimensional transvaginal sonography ", "three-dimensional transvaginal sonography with saline infusion and laparoscopy Hysteroscopy"in diagnosis of septated and bicornuate uterus uterine.
Public title
Diagnostic accuracy "three-dimensional transvaginal sonography "and "three-dimensional transvaginal sonography with saline infusion"in diagnosis of uterine anomalies.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria were as follow:
1-Child bearing age women with septated or bicornuate uterus by histerosalpingography; 2- obstetric history of miscarriage or candidate for IVF-ICSI.
Exclusion criteria:
1-18≤patient age≥45; 2-No desire for conception; 3-pregnancy; 4-uterine or cervical malignanc; 5-cervicities,vaginitiesand recent history of PID.
Age
From 18 years old to 44 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study has not control group and diagnostic interventional procedure done in all studied patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ̓s Tehran university of medical sciences
congenital malformations, deformations and chromosomal abnormalities,Congenital malformations of genital organs,Pregnancy with abortive outcome ,inborn errors of metabolism,Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
the presence of uterine anomaly
Timepoint
One to Three months before laparoscopy Hysteroscopy operation and sameday
Method of measurement
three-dimensional transvaginal sonography and three-dimensional transvaginal sonography with saline infusion and laparoscopy Hysteroscopy
Secondary outcomes
1
Description
Others uterine anomalies
Timepoint
Before and day of laparoscopy Hysteroscopy
Method of measurement
Three-dimensional transvaginal sonography and three-dimensional transvaginal sonography with saline infusion and laparoscopy Hysteroscopy
Intervention groups
1
Description
Three-dimensional transvaginal sonography
Category
Diagnosis
2
Description
Three-dimensional transvaginal sonography with saline infusion
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Mahbod Ebrahimi
Street address
Yas hospital, ّFourth alley corner, North Ostad Negatoollahi Avenue,Karimkhan street,Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences,Vice chancellor for research
Full name of responsible person
Mahbod Ebrahimi
Street address
Research Department,Floor(No:6),Central building of university,Around the corner of Ghods Aveو Keshavarz Buld,Tehran,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical sciences,Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Zahra Dehbashi
Position
Graduated student of infertility floship
Other areas of specialty/work
Street address
Yas hospital, ّFourth alley corner, North Ostad Negatoollahi Avenue,Karimkhan street,Tehran,Iran