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
45

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
Last Updated

January 20, 2026

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

January 9, 2026

Last Update Submit

January 9, 2026

Conditions

Intrauterine Device ComplicationsIUD FragmentationRetained Intrauterine DeviceFemale ContraceptionWomen's HealthReproductive HealthContraceptive Device Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Hysteroscopy Resulting from IUD Fragmentation Upon Removal

    Identify patient risk factors for Cooper IDU fragmentation upon removal requiring a hysteriscopy.

    2005-2025

Study Arms (1)

Hysteroscopy

Necessitated a hysteroscopic procedure.

Other: Hysteroscopy

Interventions

HysteroscopyOTHER

Retrospective chart review for those patients who had a hysteroscopy after IUD removal.

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

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Annabel Mancillas, MD MPH FACOG

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

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

January 20, 2026

Record last verified: 2025-08

Locations

US(1)