Intrauterine Device ComplicationsNCT07351084
Patient Factors Associated With Fragmentation of Copper Intrauterine Device (IUD) Requiring Hysteroscopic Removal
An observational study of Intrauterine Device Complications and Contraceptive Device Failure, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this retrospective chart review was to identify risks factors for patients associated to Cooper IUD fragmentation upon removal resulting in the requirement of a hysteroscopy evaluation. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Intrauterine Device Complications, Contraceptive Device Failure, IUD Fragmentation
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to 26 Jun 2025
- Phase
- Observational
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 60 years
- Women only
- Adult
Study population: Patients who underwent IUD removal at the University of Kansas Health System
Who may be able to join
- IUD removal and required hysteroscopy
Who cannot join
- Younger than 18 years old
- IU removal without requiring hysteroscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Retrospective Chart Review Study of Patient Factors Associated With Fragmentation of Copper Intrauterine Device Requiring Hysteroscopic Removal
The purpose of this retrospective chart review was to identify risks factors for patients associated to Cooper IUD fragmentation upon removal resulting in the requirement of a hysteroscopy evaluation.
- Conditions
- Intrauterine Device Complications, Contraceptive Device Failure, IUD Fragmentation, Retained Intrauterine Device, Female Contraception, Women's Health
- Keywords
- Copper IUD, ParaGard, Intrauterine device, IUD breakage, IUD retention, IUD complications, Hysteroscopy, IUD removal, IUD fracture, Gynecologic surgery, Contraception complications, Retained IUD fragment, Minimally invasive gynecology, Long-acting reversible contraception (LARC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopy | Retrospective chart review for patients who necessitated a hysteroscopic procedure from 2004-2024. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Underwent a Hysteroscopy Procedure Resulting From Intrauterine Device (IUD) Fragmentation Upon Removal
Identify patient risk factors for Cooper IDU fragmentation upon removal requiring a hysteroscopy by completing a retrospective chart review.
Measured: January 2004- December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start28 Feb 2025
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
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 Intrauterine Device ComplicationsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annabel Mancillas, MD MPH FACOG, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351084
- Sponsor's protocol ID
- STUDY00160745
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2026
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No