Clinical Evaluation of a Tubal Selective Delivery System
ConditionInfertility of Tubal Origin
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorOregon Health and Science University
About this trial
A single center study to evaluate the performance and optimize the design of a novel intrauterine catheter system intended as a nonsignificant risk medical device to aid in evaluating tubal patency as part of the initial diagnostic workup for infertility.
Eligibility criteria
Qualifiers
Literate in English
Able to understand and sign an IRB-approved informed consent form
Willing to complete a pre-procedure questionnaire
Regular menstrual cycles (24- 38 days)
Disqualifiers
Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test
Currently using hormonal contraception. Must have at least one natural cycle (two menses) prior to participation if recently discontinued hormonal contraception.
Currently using an intrauterine device (IUD). Must discontinue at least 30 days prior to Visit 2
Allergy or hypersensitive to radio-opaque contrast, ExEm foam, both doxycycline and azithromycin (allergy to one not exclusionary if can take the alternative), or lidocaine
Trial design
Treatments tested in this trial
- Tubal Selective Delivery System (TSDS)
Treatment groups
12 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov