Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion
Condition: Sterilization, Female; Fallopian Tube Occlusion
Study type: Observational

Summary: 
      The overarching goal of this study is to find an alternative method to hysterosalpingogram
      (HSG) to confirm bilateral tubal occlusion after permanent contraception.
    

Detailed description: 
      The hystero-(uterus)salpingo-(fallopian tube)graphy (HSG) study is a standard radiological
      imaging study used to evaluate the internal female reproductive parts, the uterus and
      fallopian tubes. The tubes are a passage that allows fluid and cells to flow between the body
      cavity and the uterus. Normally, both tubes are open to this flow, a condition called "tubal
      patency". If one or both tubes is blocked preventing flow of fluid, this is called "tubal
      occlusion". If there is tubal patency, as the pressure increases in the uterine cavity, fluid
      will move through the tubes into the body cavity. If the tubes are occluded, pressure will
      increase in the uterus but the fluid will not move into the tubes.

      The long-term goal is to develop an alternative test to confirm both fallopian tubes are
      blocked after a non-surgical permanent contraception (sterilization) procedure. Currently
      tubal patency is determined by HSG.

      In this study, the investigators evaluate the potential for alternative diagnostic office
      tests. The study will evaluate whether uterine pressure measurements can predict tubal
      patency, or whether the change in volume following intrauterine administration of a fixed
      volume of saline followed by aspiration predicts tubal patency.

      Prior to the instillation of contrast solution, investigators will administer a fixed volume
      of saline at a constant rate until we reach a volume of 10 ml, or the limit of tolerability
      for the patient. After a wait of 1 min, they will attempt to aspirate the saline, and measure
      the difference between fluid in and fluid out. The study will also measure intrauterine
      pressure during the procedure.

      Following the saline test, an HSG is done to assess tubal patency.

      This study will evaluate healthy parous women in the late follicular phase and women with a
      history of Essure permanent contraception.

      The investigators hypothesize that women with a history of Essure will have higher uterine
      pressure, higher volume of fluid recovered, and bilateral tubal occlusion by HSG.
    

Intervention name(s): Hysterosalpingogram (HSG)
Intervention type(s): Procedure
Intervention description(s): An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Reproductive age (18-50 years) women in the Portland-metro area with either a history of
        Essure® hysteroscopic permanent contraception or healthy control participants without
        history of a permanent contraception procedure.
      
Keywords: hysterosalpingogram (HSG); permanent contraception; tubal occlusion; tubal patency