CompletedNot Applicable

Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility

United States27 participantsStarted 2018-01-31

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Concordance between sonoHSG and HSG results. The sonoHSG and HSG will be considered interchangeable if the level of agreement between them is >= 80%.

Timeframe: 1 year

Trial details

NCT IDNCT03234569

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-05

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