Patient Factors Associated With Fragmentation of Copper Intrauterine Device (IUD) Requiring Hysteroscopic Removal

Retrospective Chart Review Study of Patient Factors Associated With Fragmentation of Copper Intrauterine Device Requiring Hysteroscopic Removal

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07351084

Enrollment

Registered

2026-01-20

Start date

2025-02-28

Completion date

2025-06-26

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Device Failure, Female Contraception, Intrauterine Device Complications, IUD Fragmentation, Reproductive Health, Retained Intrauterine Device, 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)

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Inclusion criteria

* IUD removal and required hysteroscopy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients Who Underwent a Hysteroscopy Procedure Resulting From Intrauterine Device (IUD) Fragmentation Upon Removal	January 2004- December 2024	Identify patient risk factors for Cooper IDU fragmentation upon removal requiring a hysteroscopy by completing a retrospective chart review.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnnabel Mancillas, MD MPH FACOG

University of Kansas Medical Center

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	44 Participants
Age, Customized	39.1 years STANDARD_DEVIATION 8.1
BMI	29.3 kg/m^2 STANDARD_DEVIATION 5
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	5 Participants
Race (NIH/OMB) More than one race	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants
Race (NIH/OMB) White	30 Participants
Region of Enrollment United States	44 participants
Sex: Female, Male Female	44 Participants
Sex: Female, Male Male	0 Participants
Uterine abnormality	15 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 44
serious Total, serious adverse events	0 / 0

Outcome results