Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 31, 2017
CompletedStudy Start
First participant enrolled
January 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedApril 7, 2022
April 1, 2022
2.1 years
July 28, 2017
April 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concordance between sonoHSG and HSG results. The sonoHSG and HSG will be considered interchangeable if the level of agreement between them is >= 80%.
1 year
Secondary Outcomes (1)
Quantification of level of patient pain in regard to sonoHSG versus HSG
1 year
Study Arms (1)
sonoHSG
EXPERIMENTALThis is the research procedure and it will be added onto the standard of care procedure for all subjects.
Interventions
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
You may qualify if:
- Undergoing evaluation for infertility in the Northwell Health System
- 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
You may not qualify if:
- History of active pelvic infection
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
Northwell Health- North Shore University Hospital
Manhasset, New York, 11030, United States
Related Publications (7)
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.
PMID: 23826862BACKGROUNDExacoustos 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.
PMID: 14567814BACKGROUNDMarci 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.
PMID: 23968513BACKGROUNDLuciano 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.
PMID: 24910933BACKGROUNDSchankath 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.
PMID: 22802083BACKGROUNDSzymusik 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.
PMID: 25650318BACKGROUNDHandelzalts 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.
PMID: 27160813BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Pellerito, MD
Northwell Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair, Education Department of Radiology
Study Record Dates
First Submitted
July 28, 2017
First Posted
July 31, 2017
Study Start
January 31, 2018
Primary Completion
March 5, 2020
Study Completion
March 5, 2020
Last Updated
April 7, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share