NCT07351084

Completed

Patient Factors Associated With Fragmentation of Copper Intr...

University of Kansas Medical Center Source

University of Kansas Medical Center

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

STUDY00160745

Study Type

observational

Actual enrollment (reported)

44

Locations

1 country

Sites

1

Timeline

Study Start

February 28, 2025

Actual (reported)

Primary Completion

June 26, 2025

Actual (reported)

Study Completion

June 26, 2025

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 44 participants
Study completion date: June 26, 2025
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 28, 2025
Actual (reported)
Primary Completion
June 26, 2025
Actual (reported)
Study Completion
June 26, 2025
Actual (reported)
First Submitted
January 9, 2026
Actual (reported)
First Posted
January 20, 2026
Actual (reported)
Results Posted
June 30, 2026
Actual (reported)

Last Updated: June 30, 2026
Status Verified: June 2026
Results QC Date: June 23, 2026
Last Update Submitted: June 23, 2026

Conditions

Contraceptive Device Failure Female Contraception Intrauterine Device Complications IUD Fragmentation Reproductive Health Retained Intrauterine Device Women's 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.

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:

Sponsors & Collaborators

University of Kansas Medical Center
Otherlead

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Results Point of Contact

Title: Annabel Mancillas, MD MPH FACOG
Organization: The University of Kansas Medical Center

Study Officials

Annabel Mancillas, MD MPH FACOG
University of Kansas Medical Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

44 participants (actual enrollment reported by the registry).

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

Actual (reported)

Recruiting

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Enrolling By Invitation

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Not ApplicableActive Not Recruiting

Younger than 18 years old
IU removal without requiring hysteroscopy

Contact the study team to confirm eligibility.

Primary Completion

June 26, 2025

Actual (reported)

Study Completion

June 26, 2025

Actual (reported)

Last Updated

June 30, 2026

Results First Posted

June 30, 2026

Record last verified: 2026-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07351084
Data provider: ClinicalTrials.gov
Source updated: 2026-06-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:38 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2024-05-14

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Hysteroscopy

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations