NCT07351084

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 30, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

January 9, 2026

Results QC Date

May 5, 2026

Last Update Submit

June 23, 2026

Conditions

Intrauterine Device ComplicationsIUD FragmentationRetained Intrauterine DeviceContraceptive Device FailureFemale ContraceptionWomen's HealthReproductive Health

Keywords

Copper IUDParaGardIntrauterine deviceIUD breakageIUD retentionIUD complicationsHysteroscopyIUD removalIUD fractureGynecologic surgeryContraception complicationsRetained IUD fragmentMinimally invasive gynecologyLong-acting reversible contraception (LARC)

Outcome Measures

Primary Outcomes (1)

  • 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.

    January 2004- December 2024

Study Arms (1)

Hysteroscopy

Retrospective chart review for patients who necessitated a hysteroscopic procedure from 2004-2024.

Interventions

Hysteroscopy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent IUD removal at the University of Kansas Health System

You may qualify if:

  • IUD removal and required hysteroscopy

You may not qualify if:

  • Younger than 18 years old
  • IU removal without requiring hysteroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Results Point of Contact

Title
Annabel Mancillas, MD MPH FACOG
Organization
The University of Kansas Medical Center
amancillas@kumc.edu
913-588-6200

Study Officials

  • Annabel Mancillas, MD MPH FACOG

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 20, 2026

Study Start

February 28, 2025

Primary Completion

June 26, 2025

Study Completion

June 26, 2025

Last Updated

June 30, 2026

Results First Posted

June 30, 2026

Record last verified: 2026-06

Locations

US(1)