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

February 10, 2026 updated by: University of Colorado, Denver
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mentrual Cup Removal
Menstrual Cup Removal.
Other: Menstrual Cup Removal
Participants will be asked to remove Menstrual cup by breaking the seal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
12-18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
III. The proportion of subjects who report pulling on the menstrual cup stem before breaking the seal.
Time Frame: 12-18 months
The proportion of subjects who report pulling on the menstrual cup stem before breaking the seal.
12-18 months
III. The proportion of subjects who report feeling suction during menstrual cup removal.
Time Frame: 12-18 months
The proportion of subjects who report feeling suction during menstrual cup removal.
12-18 months
III. The proportion of subjects who report palpating the IUD strings during menstrual cup removal.
Time Frame: 12-18 months
The proportion of subjects who report palpating the IUD strings during menstrual cup removal.
12-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Cara Clure, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 21-4267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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