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Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility

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ClinicalTrials.gov Identifier: NCT03234569
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
John Pellerito, Northwell Health

Brief 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.

Condition or disease Intervention/treatment Phase
Infertility, Female Procedure: sonoHSG Not Applicable

Detailed Description:

This pilot study is a collaborative effort between Northwell Health Fertility and the Radiology Department to streamline the fertility evaluation process and reduce the burden of stress many fertility patients experience by eliminating an imaging examination which is painful and exposes the patient to potentially harmful radiation.

The aim of this study is to improve the workup of infertility by integrating the examination of structural abnormalities of the fallopian tubes and uterus into a single radiation-free ultrasound guided procedure, the sonohysterosalpingogram (sonoHSG). Confirmation of tubal patency is extremely important as approximately 25-35% of female infertility can be attributed to fallopian tube pathology. The current paradigm is to use two separate imaging exams; the hysterosalpingogram (HSG), a transvaginal procedure that uses radiation and iodinated contrast to visualize the fallopian tubes, and the sonohysterogram, a transvaginal procedure that uses ultrasound and saline to visualize the uterus. By using agitated saline, to produce air bubbles, fallopian tube visualization is optimized during the time of sonohysterogram (sonoHSG). The investigators plan to also utilize a continuous saline-air device that may produce a technically superior sonoHSG.

As a result of this study, the Radiology Department and Northwell Health Fertility will work together to encourage, educate, and support physicians to promote the utility of sonoHSG as the first imaging examination for the infertility workup. Currently, this institution is not routinely utilizing the sonoHSG despite the advantages in safety, comfort, and convenience to the patient. The investigators aim to effect a change in the current practice at this institution by increasing the knowledge and visibility of the sonoHSG by creating educational materials for referring physicians, and creating a pilot program that demonstrates the value and efficacy of the exam. SonoHSG can be performed concurrently at the time of the sonohysterogram at no additional cost to the patient.

The investigators will enroll 30 patients from Northwell Health Fertility over the course of one year. Measures of success will include concordance between sonoHSG and HSG in patients who receive both procedures, and patient surveys evaluating pain utilizing the pain scale. If sonoHSG proves to be efficacious, future steps will be to educate referring physicians and patients about the utility of the examination using print materials and a grand rounds lecture. The investigators will also measure the number of sonoHSGs ordered compared to HSGs for the evaluation of fallopian tube patency in order to evaluate if there has been a shift in the standard of care.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sonoHSG
This is the research procedure and it will be added onto the standard of care procedure for all subjects.
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.




Primary Outcome Measures :
  1. Concordance between sonoHSG and HSG results. The sonoHSG and HSG will be considered interchangeable if the level of agreement between them is >= 80%. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quantification of level of patient pain in regard to sonoHSG versus HSG [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All women undergoing evaluation for infertility greater than 6 months in the Northwell Health system
  • Non-pregnant women age 18-50 years old
  • Diagnosis of ovulatory dysfunction
  • Diminished ovarian reserve, unexplained
  • Recurrent pregnancy loss

Exclusion Criteria:

  • History of active pelvic infection
  • History of tubal ligation or salpingectomy
  • History of adverse reaction to iodinated contrast
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234569


Contacts
Contact: Bakhtawar Bajwa, MPH 516-562-4796 bbajwa1@northwell.edu
Contact: Kavita Adinarayan, MS kadinaraya@northwell.edu

Locations
United States, New York
Northwell Health- North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: John Pellerito, MD    516-562-4796    jpelleri@northwell.edu   
Contact: Bakhtawar Bajwa, MPH       bbajwa1@northwell.edu   
Sponsors and Collaborators
Northwell Health
General Electric
Investigators
Principal Investigator: John Pellerito, MD Northwell Health
  Study Documents (Full-Text)

Documents provided by John Pellerito, Northwell Health:
Study Protocol  [PDF] July 26, 2017
Informed Consent Form  [PDF] July 26, 2017


Additional Information:
Publications:

Responsible Party: John Pellerito, Vice Chair, Education Department of Radiology, Northwell Health
ClinicalTrials.gov Identifier: NCT03234569     History of Changes
Other Study ID Numbers: 16-0967
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Pellerito, Northwell Health:
sonohysterosalpingography
hysterosalpingogagraphy

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female