Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02597816
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 9
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Radiation: Three dimensional ultrasound	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Three Dimensional Trans-vaginal Ultrasound to Reevaluate Arcuate Uteri Diagnosed by Hystro-salpingography
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: Three dimensional ultrasound 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

Outcome Measures

Primary Outcome Measures

1. Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
• ClinicalTrials.gov Identifier: NCT02597816
• Other Study ID Numbers: TDU
• First Posted: Nov 5, 2015
• Last Update Posted: Dec 18, 2015
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Dec 18, 2015