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IUD; Complications, MechanicalNCT05254041

Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use

A study testing Menstrual Cup Removal in people with IUD; Complications, Mechanical and Menstrual Cup, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will provide pilot data examining suction as a mechanism of IUD displacement with menstrual cup use. The investigator hypothesize that manufacturer-recommended menstrual cup insertion and removal by breaking the seal will result in 15% rate of IUD displacement/expulsion. 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; Complications, Mechanical, Menstrual Cup
What is being tested?
Menstrual Cup Removal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
20 Feb 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Between the ages of 18-45
  • Currently has an FDA approved IUD
  • Present to CWHC for IUD removal

Who cannot join

  • Known sensitivity or allergy to silicone
  • known active vaginal infection (yeast, bacterial vaginosis, untreated sexually transmitted infection)
  • IUD strings not visible
  • Positive pregnancy test

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Comprehensive Women's Health Center

    Denver, Colorado, 80230

    Eva Dindinger, MPH, 303-724-8482, Eva.Dindinger@CUAnschutz.edu

    Recruiting

Other trials in United States

About this study

This study will provide pilot data examining suction as a mechanism of IUD displacement with menstrual cup use. The investigator hypothesize that manufacturer-recommended menstrual cup insertion and removal by breaking the seal will result in 15% rate of IUD displacement/expulsion. The investigator will also use this data to explore variables associated with IUD displacement and menstrual cup use. By examining the role of suction as a possible mechanism of IUD displacement, this research will allow healthcare providers to better counsel patients who use IUDs regarding menstrual cup use. Having a better understanding of the mechanics of IUD displacement could lead to the development of strategies to prevent expulsion.

Read the detailed description

Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting, reversible contraception in the United States (US). IUD expulsions, or displacement of the IUD from the top of the uterine cavity occur approximately 5% of the time but can have significant consequences for patients such as unintended pregnancy and further need for health care services and costs. Limited data suggests that menstrual cup use with an IUD in place may be associated increased risk of IUD expulsion. Menstrual cups such as the DivaCup are reusable collection devices that are an increasingly popular alternative to tampons or sanitary pads in the US; they are more cost effective and more environmentally sustainable. The cup is placed in the vagina to create a vacuum seal to prevent leakage. This seal or suction should be released before cup removal. Two plausible mechanisms have been suggested to explain IUD expulsion in the setting of menstrual cup use: the suction created by the cup displaces the IUD, or the IUD strings are inadvertently pulled on during cup removal. No studies have examined the mechanics of IUD displacement. Additionally, there are no formal recommendations guiding patients and providers about concomitant IUD and menstrual cup use, including expulsion risk or strategies to prevent expulsions. Data are needed to not only better understand the mechanisms of IUD displacement with menstrual cup use, but to better guide the many patients who use both.

This study will address this knowledge gap by performing an exploratory study of the IUD displacement with menstrual cup insertion and removal, specifically looking at suction as a mechanism. The investigator will enroll fifty women presenting for IUD removal. Women will be screened for eligibility and participants will be excluded if they are unable to place and remove a menstrual cup, do not have visible IUD strings on exam, have a silicone allergy or sensitivity, or have an experimental IUD. After a screening pelvic exam and transvaginal ultrasound to measure the distance of the IUD from the top of the uterine fundus, the participant will be asked to place a menstrual cup as suggested by the manufacturer. Participants will then be instructed to remove the menstrual cup by breaking the suction or seal. A repeat transvaginal ultrasound will be done to re-measure the IUD location and quantify any displacement. Participants who did not have complete IUD expulsion with the first cup placement and removal will be instructed to replace the cup and then remove the cup without breaking the seal.

This study will provide pilot data examining suction as a mechanism of IUD displacement with menstrual cup use. The investigator hypothesize that manufacturer-recommended menstrual cup insertion and removal by breaking the seal will result in 15% rate of IUD displacement/expulsion. The investigator will also use this data to explore variables associated with IUD displacement and menstrual cup use. By examining the role of suction as a possible mechanism of IUD displacement, this research will allow healthcare providers to better counsel patients who use IUDs regarding menstrual cup use. Having a better understanding of the mechanics of IUD displacement could lead to the development of strategies to prevent expulsion.

Being tested
Menstrual Cup Removal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Menstrual Cup RemovalOther

    Participants will be asked to remove Menstrual cup by breaking the seal.

Study groups in NCT05254041
Study groupRoleWhat they receive
Mentrual Cup RemovalOtherMenstrual Cup Removal.
Receives: Other: Menstrual Cup Removal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of IUD displacement with manufacturer-recommended menstrual cup insertion and removal

    The rate of IUD displacement measured by the frequency of IUDs that shift >1cm after manufacturer-recommended menstrual cup insertion and removal.

    Measured: 12-18 months

Secondary outcomes (1)
  1. The rate of IUD displacement measured by the frequency of IUDs that shift >1cm after manufacturer-recommended menstrual cup insertion and removal followed by insertion and removal the menstrual cup without breaking the seal.

    The rate of IUD displacement measured by the frequency of IUDs that shift >1cm after manufacturer-recommended menstrual cup insertion and removal followed by insertion and removal the menstrual cup without breaking the seal.

    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.

  1. First posted24 Feb 2022
  2. Study start20 Feb 2022
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254041
Sponsor's protocol ID
21-4267
Status last verified
Feb 2026
First submitted
28 Jan 2022
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Menstrual Cup Removal in people with IUD; Complications, Mechanical and Menstrual Cup, 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cara Clure, MD (303-724-8482, cara.clure@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of IUD displacement with manufacturer-recommended menstrual cup insertion and removal (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?
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 12 Feb 2026.

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