Infertility Clinical Trial
Official title:
Three Dimensional Trans-vaginal Ultrasound to Reevaluate Arcuate Uteri Diagnosed by Hystro-salpingography
Verified date | October 2013 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut university | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound | 1 year | Yes |
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