Sterilization, FemaleNCT04071392
Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion
An observational study of Sterilization, Female and Fallopian Tube Occlusion, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The overarching goal of this study is to find an alternative method to hysterosalpingogram (HSG) to confirm bilateral tubal occlusion after permanent contraception. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sterilization, Female, Fallopian Tube Occlusion
- What is being tested?
- Hysterosalpingogram (HSG)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 31 Jul 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Pressure Dynamics in the Non-gravid Uterus: Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion After Nonsurgical Permanent Contraception
The overarching goal of this study is to find an alternative method to hysterosalpingogram (HSG) to confirm bilateral tubal occlusion after permanent contraception.
Read the 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.
- Conditions
- Sterilization, Female, Fallopian Tube Occlusion
- Being tested
- Hysterosalpingogram (HSG)
- Keywords
- hysterosalpingogram (HSG), permanent contraception, tubal occlusion, tubal patency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysterosalpingogram (HSG)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-Essure Group | 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. Receives: Procedure: Hysterosalpingogram (HSG) | |
| Control Group | 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. Receives: Procedure: Hysterosalpingogram (HSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (1)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sterilization, FemaleStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Womens Imaging & Intervention
- Responsible party
- Principal investigator, Jeffrey Jensen, Oregon Health and Science University
- Investigators
- Jeffrey Jensen, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071392
- Sponsor's protocol ID
- OHSU IRB 11443
- Status last verified
- Dec 2019
- First submitted
- 26 Aug 2019
- Last updated
- 10 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon consenting and enrollment, subjects will be assigned a unique study identification code that will be used instead of their name, medical record number, or other personally identifying information. Data and/or specimens from this study will be kept in a repository and may be shared using the participant's unique study identification code with other investigators for future research.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Dynamics in the Non-gravid Uterus: Development of an Intrauterine Pressure Threshold to Confirm Tubal Occlusion After Nonsurgical Permanent Contraception
- ClinicalTrials.gov ID
- NCT04071392
- Acronym / sponsor ID
- OHSU IRB 11443
- Conditions
- Sterilization, Female, Fallopian Tube Occlusion
- Keywords
- hysterosalpingogram (HSG), permanent contraception, tubal occlusion, tubal patency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Womens Imaging & Intervention
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 10 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Essure Group | – | Procedure: Hysterosalpingogram (HSG)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. |
| Control Group | – | Procedure: Hysterosalpingogram (HSG)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysterosalpingogram (HSG)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. | Procedure or surgery | Control Group, Post-Essure Group |
Primary outcome
Intrauterine Fluid Volume Lost
Time frame: 5 minutes
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.
1 secondary outcome
Tolerance of 10 ml Saline Infusion
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upon consenting and enrollment, subjects will be assigned a unique study identification code that will be used instead of their name, medical record number, or other personally identifying information. Data and/or specimens from this study will be kept in a repository and may be shared using the participant's unique study identification code with other investigators for future research.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Jensen, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sterilization, Female and Fallopian Tube Occlusion, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrauterine Fluid Volume Lost (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.