Infertility, Female Clinical Trial
Official title:
Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility
NCT number | NCT03234569 |
Other study ID # | 16-0967 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 31, 2018 |
Est. completion date | March 5, 2020 |
Verified date | April 2022 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | March 5, 2020 |
Est. primary completion date | March 5, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwell Health- North Shore University Hospital | Manhasset | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
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. — View Citation
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. — View Citation
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. Review. — View Citation
Maheux-Lacroix S, Boutin A, Moore L, Bergeron MÈ, 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quantification of level of patient pain in regard to sonoHSG versus HSG | 1 year |
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