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
- 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 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.
- More trials run by University of Kansas Medical CenterThe 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review Study of Patient Factors Associated With Fragmentation of Copper Intrauterine Device Requiring Hysteroscopic Removal
- ClinicalTrials.gov ID
- NCT07351084
- Acronym / sponsor ID
- STUDY00160745
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopy | – | –Retrospective chart review for patients who necessitated a hysteroscopic procedure from 2004-2024. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients who underwent IUD removal at the University of Kansas Health System
Key inclusion criteria (1 listed)
- IUD removal and required hysteroscopy
Key exclusion criteria (2 listed)
- Younger than 18 years old
- IU removal without requiring hysteroscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients Who Underwent a Hysteroscopy Procedure Resulting From Intrauterine Device (IUD) Fragmentation Upon Removal
Time frame: January 2004- December 2024
Identify patient risk factors for Cooper IDU fragmentation upon removal requiring a hysteroscopy by completing a retrospective chart review.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Annabel Mancillas, MD MPH FACOG principal investigator
University of Kansas Medical Center
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 Intrauterine Device Complications and Contraceptive Device Failure, run by University of Kansas Medical Center 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 1 inclusion and 2 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 30 Jun 2026. 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 30 Jun 2026). 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?
Number of Patients Who Underwent a Hysteroscopy Procedure Resulting From Intrauterine Device (IUD) Fragmentation Upon Removal (time frame: January 2004- December 2024). 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 30 Jun 2026.