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

NCT03777358 | Unknown

• 1 other identifier: MD.18.10.99
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Three-dimensional transvaginal ultrasonography (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.

Device: 3D-TVS

Interventions

3D-TVS DEVICE

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

Three-dimensional transvaginal ultrasonography (3D-TVS)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Infertile women (primary or secondary) aged between 18 and 40 years.

You may qualify if:

• Infertile women (primary or secondary)
• Age between 18 and 40 years.

You may not qualify if:

• age\<18 years and˃ 40 years.
• pelvic inflammatory disease.
• Active uterine bleeding

Sponsors & Collaborators

• Hatem AbuHashim: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related 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.

  PMID: 24639723 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Hatem Abu Hashim, MD. FRCOG. PhD

  Faculty of Medicine, Mansoura University

  STUDY CHAIR

• Mohamed Fekry, MSc

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

EG (1)