Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women

Female Infertility Clinical Trial

Official title:

A Prospective Study Comparing Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03777358
• Other study ID #: MD.18.10.99
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: July 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hysteroscopy has now become a gold-standard technique carried out for uterine cavity assessment in infertile women. Apart from direct visualizing of the endometrium by the naked eye, pathologies missed by other modalities of investigation can be picked up and managed appropriately. Unfortunately, the procedure itself is not free from complications e.g. perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and considered as an invasive procedure.

Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in identifying uterine cavity abnormalities due to its ability to obtain a view of three different planes of the uterus, which could be used to locate the position of intracavitary pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have 41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but its sensitivity, specificity and accuracy still a matter of debate and warrants more evaluation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Infertile women (primary or secondary)

• Age between 18 and 40 years.

Exclusion Criteria:

• age<18 years and? 40 years.

• pelvic inflammatory disease.

• .Active uterine bleeding

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Device:
• 3D-TVS
The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then hysteroscopy will be performed

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansourah	Dakahlia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Hatem AbuHashim

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Ahmadi F, Rashidy Z, Haghighi H, Akhoond M, Niknejadi M, Hemat M, Shamsipour M. Uterine cavity assessment in infertile women: Sensitivity and specificity of three-dimensional Hysterosonography versus Hysteroscopy. Iran J Reprod Med. 2013 Dec;11(12):977-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of 3D-TVS	The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women.	At 1 week postmenstrual