Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pressure Dynamics in the Non-gravid Uterus: Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion After Nonsurgical Permanent Contraception

Conditions
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Sterilization, Female, Fallopian Tube Occlusion

Intervention / Treatment
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* Procedure: Hysterosalpingogram (HSG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Literate in English Ages 18-50 years No history of infertility, and current regular menstrual cycles occurring every 24-37 days At least one full-term vaginal delivery Not be at risk for pregnancy Be willing to undergo a one month washout period if using the pill, patch or ring, or a three month wash out period if using Depo-Medroxyprogesterone acetate (DMPA) Willing to undergo intrauterine saline infusion followed by a single HSG procedure Able to understand and sign approved study informed consent form Willing to complete a pre-procedure questionnaire Exclusion Criteria: Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test Currently using an intrauterine device (IUD) or contraceptive implant Hypersensitive to radio-opaque contrast History of cesarean section History of tubal ligation by a method other than Essure® or Adiana History recognized as clinically significant by the investigator, such as symptoms of untreated or recent pelvic infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-Essure Group<br>Healthy women with history of Essure hysteroscopic permanent contraception. Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities. | Procedure: Hysterosalpingogram (HSG)<br>* 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.<br>|
| Control Group<br>Healthy women with no history of permanent contraception. Eligible participants will then undergo the HSG imaging study - a standard radiological imaging study to determine that the fallopian tubes are open and free of disease. It also checks the uterine cavity for any abnormalities. | Procedure: Hysterosalpingogram (HSG)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrauterine Fluid Volume Lost | After placement of the hysterosalpingogram catheter, investigators use an infusion pump to deliver normal saline under continuous pressure monitoring until reaching one of the following endpoints: delivery of the entire volume of 10mL (milliliter); a peak pressure of 450mmHg (millimeters of Mercury); or the participant requested the infusion to stop due to intolerable discomfort. After one minute, investigators withdraw the delivered fluid through the hysterosalpingogram catheter and record the volume instilled and recovered. They then repeat the procedure using contrast under fluoroscopy to confirm tubal patency or occlusion. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of 10 ml Saline Infusion | After placement of the hysterosalpingogram catheter, investigators use an infusion pump to deliver normal saline under continuous pressure monitoring until reaching one of the following endpoints: delivery of the entire volume of 10mL (milliliter); a peak pressure of 450mmHg (millimeters of Mercury); or the participant requested the infusion to stop due to intolerable discomfort. The proportion of participants who tolerated the full 10 ml of infused saline was compared between groups. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysterosalpingogram (HSG), permanent contraception, tubal occlusion, tubal patency