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Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility

NCT03234569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-04-07

No results posted yet for this study

Summary

This pilot study is a collaborative effort between Northwell Health's Departments of Fertility and Radiology.The aim of this study is to evaluate the feasibility of the Sonohysterosalpingography (sonoHSG) for it to be determined as the standard of care. Additionally, it aims to improve the work up of infertility by integrating the examination of structural abnormalities of the Fallopian tubes and uterus into a single radiation free ultrasound guided procedure, the sonoHSG.

Conditions

  • Infertility, Female

Interventions

PROCEDURE

sonoHSG

This procedure uses agitated saline to produce air bubbles at the time of the Sonohysterogram which optimizes fallopian tube visualization. The sonoHSG is free of radiation and use of contrast. In this study, in order to produce the air bubbles at the time of the sonohysterogram, the investigators will be using a continuous saline-air device that may produce a technically superior image. For the ultrasound images, General Electric will be supporting us by providing us the Voluson E10 and RIC5-9-D.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • John Pellerito, MD · Northwell Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2020-03-05
Completion
2020-03-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234569 on ClinicalTrials.gov