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.
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
- Recruiting
Comprehensive Women's Health Center
Denver, Colorado, 80230
Eva Dindinger, MPH, 303-724-8482, Eva.Dindinger@CUAnschutz.edu
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.
- Conditions
- IUD; Complications, Mechanical, Menstrual Cup
- 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 group | Role | What they receive |
|---|---|---|
| Mentrual Cup Removal | Other | Menstrual Cup Removal. Receives: Other: Menstrual Cup Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted24 Feb 2022
- Study start20 Feb 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD; Complications, MechanicalStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use
- ClinicalTrials.gov ID
- NCT05254041
- Acronym / sponsor ID
- 21-4267
- Conditions
- IUD; Complications, Mechanical, Menstrual Cup
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2022 (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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mentrual Cup Removal | Other | Other: Menstrual Cup RemovalMenstrual Cup Removal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Between the ages of 18-45
- Currently has an FDA approved IUD
- Present to CWHC for IUD removal
Key exclusion criteria (4 listed)
- Known sensitivity or allergy to silicone
- known active vaginal infection (yeast, bacterial vaginosis, untreated sexually transmitted infection)
- IUD strings not visible
- Positive pregnancy test
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 |
|---|---|---|
| Menstrual Cup RemovalParticipants will be asked to remove Menstrual cup by breaking the seal. | Other | Mentrual Cup Removal |
Primary outcome
The rate of IUD displacement with manufacturer-recommended menstrual cup insertion and removal
Time frame: 12-18 months
The rate of IUD displacement measured by the frequency of IUDs that shift >1cm after manufacturer-recommended menstrual cup insertion and removal.
1 secondary outcome
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.
Time frame: 12-18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Daniels K, Daugherty J, Jones J, Mosher W. Current Contraceptive Use and Variation by Selected Characteristics Among Women Aged 15-44: United States, 2011-2013. Natl Health Stat Rep. 2015; 86:1-14.Link provided by the sponsor.
- Daniels K, Abma JC. Current Contraceptive Status Among Women Aged 15-49: United States, 2017-2019. NCHS Data Brief. 2020:1-8.Link provided by the sponsor.
- Kaiser Family Foundation. Intrauterine Devices (IUDs): Access for Women in the U.S.Link provided by the sponsor.
- U.S. Food and Drug Administration Prescribing Information: Mirena (levonorgestrel-releasing intrauterine system). Reference ID: 3837008.Link provided by the sponsor.
- U.S. Food and Drug Administration Prescribing Information: ParaGard (intrauterine copper contraceptive). Reference ID: 3321877.Link provided by the sponsor.
- Teal SB, Turok DK, Chen BA, Kimble T, Olariu AI, Creinin MD. Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System. Obstet Gynecol. 2019;133:63-70.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
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 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.