IUD Threads Not VisibleNCT05702242
A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques
A study testing IUD removal with no visible strings, Alligator forceps and Manual Vacuum Aspirator in people with IUD Threads Not Visible and IUD Removal Complication, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Threads Not Visible, IUD Removal Complication
- What is being tested?
- IUD removal with no visible strings, Alligator forceps and Manual Vacuum Aspirator
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Ages 18 - 45 years old
- Confirmed intrauterine IUD by pelvic ultrasound
- Desires IUD removal
Who cannot join
- Currently pregnant
- IUD strings are visible
- Partial retained IUD (e.g. IUD arm only)
- Unwilling to be randomized to either arm
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Women's Health Center
Denver, Colorado, 80230
About this study
Official title: A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques: Alligator Forceps Versus Manual Vacuum Aspiration (MVA)
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.
Read the detailed description
Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting reversible contraception in the United States. Approximately 4-18% of people with an IUD in place with have missing or non-visible IUD strings, mostly commonly due to IUD string retraction into the cervix. Currently, expert opinion suggests to remove IUDs with no visible strings using by using an alligator forceps that is placed into the uterine cavity with or without ultrasound guidance. Removal of no strings IUDs with manual vacuum aspiration (MVA) has been suggested as a possible alternative to alligator forceps. MVA is a commonly used technique for the management of miscarriage, abortion, and endometrial sampling and has potential benefits as a low cost, portable device that is readily available in family planning clinic and many office-based obstetrics and gynecology practices.
The study will compare MVA to alligator forceps for IUD removal with no visible strings. The investigators will enroll females presenting for no strings IUD removals. Potential participants will be screened for eligibility and will be excluded if they have visible IUD strings, have a positive pregnancy test, have a partially retained IUD (e.g., IUD arm only), or are unwilling to be randomized to either arm. The investigators will perform a screening pelvic exam and transvaginal ultrasound (if not already completed prior to the visit). Participants will then be randomized to one of the two removal techniques: MVA or alligator forceps. The investigators will document successful removal with the first pass of the instrument as well as successful removal with multiple attempts of the same technique. A maximum of 3 MVA removal attempts will be performed after which time, the provider will switch to using an alligator forceps as the current standard of care. Preliminary data will also be collected on patient and provider satisfaction, patient pain scores, procedure time, and complications.
This study will provide important data on MVA as a technique for IUD removals with no visible strings. No studies have compared IUD removal techniques and expanding options for removal techniques has the potential to increase access to care.
- Conditions
- IUD Threads Not Visible, IUD Removal Complication
- Being tested
- IUD removal with no visible strings, Alligator forceps, Manual Vacuum Aspirator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD removal with no visible stringsProcedure or surgery
Removal with either alligator forceps or MVA
Alligator forcepsDevice
IUD removal with alligator forceps
Manual Vacuum AspiratorDevice
Also called Ipas 60-mL double valve aspirator
IUD removal with MVA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: IUD removal with no visible strings; Device: 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. Receives: Procedure: IUD removal with no visible strings; Device: Manual Vacuum Aspirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-18 months
Secondary outcomes (1)
Overall IUD removal success rates
To describe the overall success rates of IUD removal with no visible strings using alligator forceps versus manual vacuum aspiration.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for IUD Threads Not VisibleStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cara Clure, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702242
- Sponsor's protocol ID
- 22-2177
- Status last verified
- Sep 2024
- First submitted
- 5 Jan 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21237334Marchi 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.
PubMed 22459233Verma 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.
PubMed 25708503Swenson 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.
PubMed 24835830Mizia 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.
PubMed 23802598da 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.
PubMed 34197636Wu 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.
PubMed 21354074Jain 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.
PubMed 34566303Guillebaud J, Kasonde JM. A simple scheme for managing the problem of 'lost threads' with intrauterine devices. Fertil Contracept. 1979 Apr;3(2):24-32.
PubMed 12309485
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of No Strings Intrauterine Device (IUD) Removal Techniques: Alligator Forceps Versus Manual Vacuum Aspiration (MVA)
- ClinicalTrials.gov ID
- NCT05702242
- Acronym / sponsor ID
- 22-2177
- Conditions
- IUD Threads Not Visible, IUD Removal Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting reversible contraception in the United States. Approximately 4-18% of people with an IUD in place with have missing or non-visible IUD strings, mostly commonly due to IUD string retraction into the cervix. Currently, expert opinion suggests to remove IUDs with no visible strings using by using an alligator forceps that is placed into the uterine cavity with or without ultrasound guidance. Removal of no strings IUDs with manual vacuum aspiration (MVA) has been suggested as a possible alternative to alligator forceps. MVA is a commonly used technique for the management of miscarriage, abortion, and endometrial sampling and has potential benefits as a low cost, portable device that is readily available in family planning clinic and many office-based obstetrics and gynecology practices.
The study will compare MVA to alligator forceps for IUD removal with no visible strings. The investigators will enroll females presenting for no strings IUD removals. Potential participants will be screened for eligibility and will be excluded if they have visible IUD strings, have a positive pregnancy test, have a partially retained IUD (e.g., IUD arm only), or are unwilling to be randomized to either arm. The investigators will perform a screening pelvic exam and transvaginal ultrasound (if not already completed prior to the visit). Participants will then be randomized to one of the two removal techniques: MVA or alligator forceps. The investigators will document successful removal with the first pass of the instrument as well as successful removal with multiple attempts of the same technique. A maximum of 3 MVA removal attempts will be performed after which time, the provider will switch to using an alligator forceps as the current standard of care. Preliminary data will also be collected on patient and provider satisfaction, patient pain scores, procedure time, and complications.
This study will provide important data on MVA as a technique for IUD removals with no visible strings. No studies have compared IUD removal techniques and expanding options for removal techniques has the potential to increase access to care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removal with alligator forceps | Experimental | Procedure: IUD removal with no visible strings, Device: Alligator forcepsStandard 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. |
| Removal with manual vacuum aspiration | Experimental | Procedure: IUD removal with no visible strings, Device: Manual Vacuum AspiratorIntrauterine 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Ages 18 - 45 years old
- Confirmed intrauterine IUD by pelvic ultrasound
- Desires IUD removal
Key exclusion criteria (4 listed)
- Currently pregnant
- IUD strings are visible
- Partial retained IUD (e.g. IUD arm only)
- Unwilling to be randomized to either arm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IUD removal with no visible stringsRemoval with either alligator forceps or MVA | Procedure or surgery | Removal with alligator forceps, Removal with manual vacuum aspiration |
| Alligator forcepsIUD removal with alligator forceps | Device | Removal with alligator forceps |
| Manual Vacuum AspiratorAlso: Ipas 60-mL double valve aspiratorIUD removal with MVA | Device | Removal with manual vacuum aspiration |
Primary outcome
First-pass IUD removal rates
Time frame: 12-18 months
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.
1 secondary outcome
Overall IUD removal success rates
Time frame: 12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 21237334Prabhakaran 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.
- Background: PubMed 22459233Marchi 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.
- Background: PubMed 25708503Verma 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.
- Background: PubMed 24835830Swenson 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.
- Background: PubMed 23802598Mizia 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.
- Background: PubMed 34197636da 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.
- Background: PubMed 21354074Wu 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.
- Background: PubMed 34566303Jain 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.
- Background: PubMed 12309485Guillebaud J, Kasonde JM. A simple scheme for managing the problem of 'lost threads' with intrauterine devices. Fertil Contracept. 1979 Apr;3(2):24-32.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara Clure, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD removal with no visible strings, Alligator forceps and Manual Vacuum Aspirator in people with IUD Threads Not Visible and IUD Removal Complication, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-pass IUD removal rates (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702242, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.