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Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

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ClinicalTrials.gov Identifier: NCT02597816
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
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 : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound [ Time Frame: 1 year ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597816


Locations
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Egypt
Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02597816     History of Changes
Other Study ID Numbers: TDU
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: October 2013
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female