NCT05702242

Brief Summary

The goal of this clinical trial is to compare success rates of two removal techniques for intrauterine devices (IUDs) that have missing or non-visible strings. The investigators will also collect preliminary data to better understand patient and provider satisfaction, maximum pain score, procedure time, and complications with the two techniques. Participants will be randomized to IUD removal with either an alligator forceps or manual vacuum aspiration (MVA) technique. This study will provide important data on these removal techniques, which could possibly expand options for and access to no strings IUD removals.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

January 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

January 5, 2023

Last Update Submit

September 27, 2024

Conditions

IUD Threads Not VisibleIUD Removal Complication

Outcome Measures

Primary Outcomes (1)

  • First-pass IUD removal rates

    To compare the first-pass intrauterine device (IUD) removal rates of using manual vacuum aspiration versus alligator forceps for IUD removal with no visible strings.

    12-18 months

Secondary Outcomes (1)

  • Overall IUD removal success rates

    12-18 months

Other Outcomes (4)

  • Preliminary data on satisfaction

    12-18 months

  • Preliminary data on pain scores

    12-18 months

  • Preliminary data on procedure time

    12-18 months

  • +1 more other outcomes

Study Arms (2)

Removal with alligator forceps

EXPERIMENTAL

Standard of care removal with passage of an intrauterine alligator forceps under ultrasound guidance to grasp and remove the IUD. If required, multiple attempts will be performed using this technique.

Procedure: IUD removal with no visible stringsDevice: Alligator forceps

Removal with manual vacuum aspiration

EXPERIMENTAL

Intrauterine placement of an MVA under ultrasound guidance adjacent to the IUD to remove the IUD. Multiple attempts will be performed up to a maximum of 3 unsuccessful MVA attempts, after which time, the provider will switch to the alligator forceps technique, given that this is the current standard of care.

Procedure: IUD removal with no visible stringsDevice: Manual Vacuum Aspirator

Interventions

IUD removal with no visible stringsPROCEDURE

Removal with either alligator forceps or MVA

Removal with alligator forcepsRemoval with manual vacuum aspiration
Alligator forcepsDEVICE

IUD removal with alligator forceps

Removal with alligator forceps
Manual Vacuum AspiratorDEVICE

IUD removal with MVA

Also known as: Ipas 60-mL double valve aspirator
Removal with manual vacuum aspiration

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Ages 18 - 45 years old
  • Confirmed intrauterine IUD by pelvic ultrasound
  • Desires IUD removal

You may not qualify if:

  • Currently pregnant
  • IUD strings are visible
  • Partial retained IUD (e.g. IUD arm only)
  • Unwilling to be randomized to either arm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Women's Health Center

Denver, Colorado, 80230, United States

Location

Related Publications (9)

  • Prabhakaran S, Chuang A. In-office retrieval of intrauterine contraceptive devices with missing strings. Contraception. 2011 Feb;83(2):102-6. doi: 10.1016/j.contraception.2010.07.004. Epub 2010 Aug 23. No abstract available.

    PMID: 21237334BACKGROUND

  • Marchi NM, Castro S, Hidalgo MM, Hidalgo C, Monteiro-Dantas C, Villarroeal M, Bahamondes L. Management of missing strings in users of intrauterine contraceptives. Contraception. 2012 Oct;86(4):354-8. doi: 10.1016/j.contraception.2012.01.018. Epub 2012 Mar 27.

    PMID: 22459233BACKGROUND

  • Verma U, Astudillo-Davalos FE, Gerkowicz SA. Safe and cost-effective ultrasound guided removal of retained intrauterine device: our experience. Contraception. 2015 Jul;92(1):77-80. doi: 10.1016/j.contraception.2015.02.008. Epub 2015 Feb 21.

    PMID: 25708503BACKGROUND

  • Swenson C, Royer PA, Turok DK, Jacobson JC, Amaral G, Sanders JN. Removal of the LNG IUD when strings are not visible: a case series. Contraception. 2014 Sep;90(3):288-90. doi: 10.1016/j.contraception.2014.04.007. Epub 2014 Apr 21.

    PMID: 24835830BACKGROUND

  • Mizia K, Ramsay P. The effectiveness and safety of ultrasound-guided removal of a Mirena((R)) intrauterine system when the strings are not visible and conventional office procedures have failed. Aust N Z J Obstet Gynaecol. 2013 Aug;53(4):386-8. doi: 10.1111/ajo.12103. Epub 2013 Jun 26.

    PMID: 23802598BACKGROUND

  • da Silva Nobrega AB, Pitangui ACR, Vieira CS. Factors associated with missing strings and expulsion after postplacental insertion of copper T380A intrauterine devices. Int J Gynaecol Obstet. 2022 Apr;157(1):67-75. doi: 10.1002/ijgo.13806. Epub 2021 Jul 27.

    PMID: 34197636BACKGROUND

  • Wu JP, Porch E, Womack JP. Successful retrieval of an intrauterine device with "missing strings" using a manual vacuum aspirator in a desired early pregnancy: case report. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):254-6. doi: 10.1016/j.jmig.2010.11.008.

    PMID: 21354074BACKGROUND

  • Jain A, Singh S, Elliyas S. Effectiveness of Manual Vacuum Aspiration (MVA) Device in the Management of Intrauterine Copper Devices (IUCD) with Missing Strings: A Prospective Interventional Study. J Obstet Gynaecol India. 2021 Aug;71(4):424-429. doi: 10.1007/s13224-021-01440-x. Epub 2021 Mar 15.

    PMID: 34566303BACKGROUND

  • Guillebaud J, Kasonde JM. A simple scheme for managing the problem of 'lost threads' with intrauterine devices. Fertil Contracept. 1979 Apr;3(2):24-32.

    PMID: 12309485BACKGROUND

Study Officials

  • Cara Clure, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 27, 2023

Study Start

January 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

October 1, 2024

Record last verified: 2024-09

Locations

US(1)