Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility
NCT ID: NCT03234569
Last Updated: 2022-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
27 participants
INTERVENTIONAL
2018-01-31
2020-03-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up
NCT05882188
Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
NCT02505555
Sonohysterography , 3D Ultrasonography and Hysteroscopy in Assessment of Uterine Factor in Cases of Female Infertility
NCT02399501
Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients
NCT06332027
Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
NCT01537276
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
sonoHSG
This is the research procedure and it will be added onto the standard of care procedure for all subjects.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Non-pregnant women age 18-50 years old
* Subject is not menstruating at the time of study
* Provide written informed consent and written HIPAA authorization prior to study initiation
* Willing to comply with the specified follow-up evaluation schedule
Exclusion Criteria
* History of tubal ligation or salpingectomy
* History of adverse reaction to iodinated contrast
* Subject is pregnant
* Subject is menstruating at time of study
* Subject is unable to participate in study evaluations pre- and post-treatment
18 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwell Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
John Pellerito
Vice Chair, Education Department of Radiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John Pellerito, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwell Health- North Shore University Hospital
Manhasset, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Maheux-Lacroix S, Boutin A, Moore L, Bergeron ME, Bujold E, Laberge PY, Lemyre M, Dodin S. Hysterosalpingosonography for diagnosing tubal occlusion in subfertile women: a systematic review protocol. Syst Rev. 2013 Jul 4;2:50. doi: 10.1186/2046-4053-2-50.
Exacoustos C, Zupi E, Carusotti C, Lanzi G, Marconi D, Arduini D. Hysterosalpingo-contrast sonography compared with hysterosalpingography and laparoscopic dye pertubation to evaluate tubal patency. J Am Assoc Gynecol Laparosc. 2003 Aug;10(3):367-72. doi: 10.1016/s1074-3804(05)60264-2.
Marci R, Marcucci I, Marcucci AA, Pacini N, Salacone P, Sebastianelli A, Caponecchia L, Lo Monte G, Rago R. Hysterosalpingocontrast sonography (HyCoSy): evaluation of the pain perception, side effects and complications. BMC Med Imaging. 2013 Aug 23;13:28. doi: 10.1186/1471-2342-13-28.
Luciano DE, Exacoustos C, Luciano AA. Contrast ultrasonography for tubal patency. J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):994-8. doi: 10.1016/j.jmig.2014.05.017. Epub 2014 Jun 6.
Schankath AC, Fasching N, Urech-Ruh C, Hohl MK, Kubik-Huch RA. Hysterosalpingography in the workup of female infertility: indications, technique and diagnostic findings. Insights Imaging. 2012 Oct;3(5):475-83. doi: 10.1007/s13244-012-0183-y. Epub 2012 Jul 17.
Szymusik I, Grzechocinska B, Marianowski P, Kaczynski B, Wielgos M. Factors influencing the severity of pain during hysterosalpingography. Int J Gynaecol Obstet. 2015 May;129(2):118-22. doi: 10.1016/j.ijgo.2014.11.015. Epub 2015 Jan 27.
Handelzalts JE, Levy S, Peled Y, Binyamin L, Wiznitzer A, Goldzweig G, Krissi H. Information seeking and perceptions of anxiety and pain among women undergoing hysterosalpingography. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:41-4. doi: 10.1016/j.ejogrb.2016.04.037. Epub 2016 Apr 30.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Sonohysterosalpingography: A suitable choice in infertility work up
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-0967
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.