- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05339555
IUD Self-Removal Study
April 22, 2026 updated by: Jessica Reid, Oregon Health and Science University
IUD Self-Removal: A Study to Pilot the Feasibility of a Novel Technique
This is a pilot study designed to test the effectiveness of several techniques for intrauterine device (IUD) self-removal and to understand patient preferences regarding IUD self-removal and indicators of success as well as understanding the impacts of IUD self-removal on other clinical care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Investigators propose to test a novel method for self-removal of IUDs in an effort to increase the proportion of patients who are able to successfully and safely remove their IUD when desired.
Participants will attempt self-removal in office, where a provider will be able to remove the IUD if unsuccessful.
Participants will be instructed on current and novel techniques and the investigators will examine indicators of success as well as patient and provider preferences.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science Univeristy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Presenting at clinic for IUD removal or exchange
- Willing and able to give consent with literacy in English or Spanish
Exclusion Criteria:
- Participants who are referred for a complicated IUD removal such as a stingless IUD, prior failed IUD removal attempt, or an IUD failure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: IUD Self-Removal
|
The provider will offer any individual presenting for in-person IUD removal or exchange (removal-replacement) the option for self-removal.
The participant will be provided a 'how to' instruction sheet with information on positioning and what to expect.
The participant will first attempt removal with clean hands if desired, then utilizing non-sterile, clean gloves (not explicitly tested in prior studies) and if that fails, the use of a menstrual cup (a novel technique).
If not successful, the provider will perform standard IUD removal in the clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of IUD Self-Removal Techniques
Time Frame: Immediately after IUD Removal
|
Proportion of participants who successfully remove their IUDs
|
Immediately after IUD Removal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jessica Reid, MD, Oregon Health and Science University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2022
Primary Completion (Actual)
October 20, 2025
Study Completion (Actual)
October 20, 2025
Study Registration Dates
First Submitted
April 15, 2022
First Submitted That Met QC Criteria
April 15, 2022
First Posted (Actual)
April 21, 2022
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00023967
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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