Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

Infertility Clinical Trial

Official title:

Three Dimensional Trans-vaginal Ultrasound to Reevaluate Arcuate Uteri Diagnosed by Hystro-salpingography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597816
• Other study ID #: TDU
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2015
• Last updated: December 17, 2015
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2013
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Congenital uterine anomalies are found in 8% of infertile women and 24.5% of infertile women with a history of recurrent miscarriage, with septate and sub-septate uterus being the most common anomalies in these women, Also, septate uterus is the commonest anomaly found in infertile women requiring assisted reproductive technology.

Published data showed improved Cumulative pregnancy rate and live birth rate, and a significant reduction in Miscarriage rate in In Vitro Fertilization women after hysteroscopic metroplasty of both small and large septate compared to non-operated women.

Investigators hypothesized that trans-vaginal three Dimensional Ultrasound will be superior to Hystro-salpingography for the differentiation between arcuate and septate uterus in infertile women scheduled for In Vitro Fertilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• women with primary infertility,

• an indication for IVF and

• Suspected arcuate or septate uterus diagnosis based on hysterosalpingography .

Exclusion Criteria:

• were confirmed uterine abnormality by prior office hysteroscopy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infertility

Intervention

Radiation:
• Three dimensional ultrasound

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound		1 year	Yes