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OpenTrials
Completed

NCT Number: NCT02597816

Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

three dimensional ultrasound

Radiation

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2015
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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