Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

NCT02597816 | Completed Phase 2

• 1 other identifier: TDU
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound

  1 year

Study Arms (1)

Three dimensional ultrasound

OTHER

Infertile women with diagnosis of arcuate and septate uterus based on Hystro-salpingography were recruited. All women were examined by Three dimensional ultrasound on day 22 cycle to allow for better delineation of the uterine contour. The outer and inner fundal contours and the length of the fundal notch were examined by Three dimensional ultrasound in the mid-coronal view of the multi-planar and multi-slice display of the uterus. The final diagnosis of the anomalies was based on combined hysteroscopy/laparoscopy examination, the gold standard.

Radiation: Three dimensional ultrasound

Interventions

Three dimensional ultrasound RADIATION

Three dimensional ultrasound

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women with primary infertility,
• an indication for IVF and
• Suspected arcuate or septate uterus diagnosis based on hysterosalpingography .

You may not qualify if:

• were confirmed uterine abnormality by prior office hysteroscopy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 5, 2015
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 18, 2015

Record last verified: 2013-10

Locations

EG (1)