NCT05339555

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

April 15, 2022

Last Update Submit

April 22, 2026

Conditions

IUD

Keywords

IUD Removal

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of IUD Self-Removal Techniques

    Proportion of participants who successfully remove their IUDs

    Immediately after IUD Removal

Study Arms (1)

IUD Self-Removal

OTHER
Other: Instructions for IUD Self-Removal Provided to Participant

Interventions

Instructions for IUD Self-Removal Provided to ParticipantOTHER

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.

IUD Self-Removal

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Presenting at clinic for IUD removal or exchange
  • Willing and able to give consent with literacy in English or Spanish

You may not qualify if:

  • Participants who are referred for a complicated IUD removal such as a stingless IUD, prior failed IUD removal attempt, or an IUD failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science Univeristy

Portland, Oregon, 97239, United States

Location

Study Officials

  • Jessica Reid, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 21, 2022

Study Start

June 10, 2022

Primary Completion

October 20, 2025

Study Completion

October 20, 2025

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

US(1)