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

• Conditions: Female Infertility
• Interventions: Device: 3D-TVS

• Registration Number: NCT03777358
• Lead Sponsor: Hatem AbuHashim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-17
• Study Start: 2019-01-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-13
• Last Update Posted: 2019-07-16
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Three-dimensional transvaginal ultrasonography (3D-TVS)	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of 3D-TVS	At 1 week postmenstrual	The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women.

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansourah, Dakahlia Governorate, Egypt