Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion

Completed

Conditions studied: Sterilization, Female, Fallopian Tube Occlusion

In brief

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

Key facts

Study ID

NCT04071392

Run by

Oregon Health and Science University

People needed

24

Starts

2016-09-01

Expected to finish

2017-07-31

Last updated by the study team

2019-12-10

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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