NCT02398630

Brief Summary

Abstract: Recent advances in reproductive medicine have generated a demand for more accurate imaging methods for identifying the specific cause of female infertility and other gynecologic disorders. Virtual hysterosalpingography is an emerging modality in which aspects of the established technique of hysterosalpingography are combined with the cutting-edge technology of multidetector computed tomography (CT) to allow a comprehensive and highly accurate evaluation of both the female reproductive system and the pelvic anatomy generally. Unlike ultrasonography (US) and magnetic resonance (MR) imaging, multidetector CT is capable of depicting both the external and internal surfaces of the uterus, fallopian tubes, and other pelvic organs, providing high-resolution data that are suitable for two- and three-dimensional reconstructions and virtual endoscopic views. Thus, virtual hysterosalpingography may prove to be superior to other noninvasive modalities for evaluating tubal patency. Moreover, in comparison with conventional hysterosalpingography, which may involve cervical clamping, virtual hysterosalpingography is painless. Because of the health risks associated with ionizing radiation, the use of another modality (eg, MR imaging, US) may be preferred if the presence of a focal uterine lesion is strongly suspected. However, virtual hysterosalpingography with multidetector CT may provide a diagnostic advantage in complex cases.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

March 20, 2015

Last Update Submit

May 31, 2016

Conditions

Women Infertility

Keywords

HisterosalpingographyMRIMagnetic Resonance ImagingHSGDiagnostico MaipuImagingCarrascosa Patricia

Outcome Measures

Primary Outcomes (2)

  • Tubal patency

    Evaluation of the tubal patency between CT and MRI

    Six months

  • Endocavitary pathology

    Evaluation of endocavitary pathology between US, CT and MRI

    Six months

Secondary Outcomes (1)

  • Antral follicle count

    Six months

Study Arms (1)

Open Label

OTHER

This is a single arm open label study. Its procedures involve: * Transvaginal Echography * Conventional Virtual Histerosalpingography * Virtual Histerosalpingography by MRI * Blood draw for Antimullerian Hormone Dosing

Radiation: TC Virtual HysterosalpingographyOther: MRI Virtual HysterosalpingographyOther: Antimullerian Hormone dosingOther: Transvaginal Echography

Interventions

TC Virtual HysterosalpingographyRADIATION

Virtual hysterosalpingography: a new multidetector CT technique for evaluating the female reproductive system

Also known as: HSG-V
Open Label
MRI Virtual HysterosalpingographyOTHER

Magnetic Resonance Imaging Virtual hysterosalpingography

Also known as: HSG-MRI
Open Label
Antimullerian Hormone dosingOTHER

Blood Draw for Antimullerian Hormone dosing

Open Label
Transvaginal EchographyOTHER

Transvaginal Echography for evaluating the female reproductive system

Also known as: TV-Echo
Open Label

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Requested Virtual Hysterosalpingography.
  • Diagnosis of Infertility.
  • Informed Consent.

You may not qualify if:

  • Pregnancy at the time of examination.
  • Carriers of pacemaker devices.
  • Ferromagnetic elements incompatible with MRI.
  • Claustrophobia.
  • Allergy to iodine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diagnostico Maipu

Vicente López, Buenos Aires, 1638, Argentina

RECRUITING

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

March 25, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

AR(1)