Brief 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. 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

8mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.9 years study duration

Study Progress87%

Feb 2022Dec 2026

First Submitted

Initial submission to the registry

January 28, 2022

Completed

23 days until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

January 28, 2022

Last Update Submit

February 10, 2026

Conditions

IUD; Complications, Mechanical Menstrual Cup

Outcome Measures

Primary Outcomes (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.
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.
12-18 months

Other Outcomes (3)

III. 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.
12-18 months
III. The proportion of subjects who report palpating the IUD strings during menstrual cup removal.
12-18 months

Study Arms (1)

Mentrual Cup Removal

OTHER

Menstrual Cup Removal.

Other: Menstrual Cup Removal

Interventions

Menstrual Cup RemovalOTHER

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

Mentrual Cup Removal

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsLimited to only females as IUDs are only approved for females

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Colorado, Denverlead

Study Sites (1)

Comprehensive Women's Health Center

Denver, Colorado, 80230, United States

RECRUITING

Study Officials

Cara Clure, MD
University of Colorado, Denver
PRINCIPAL INVESTIGATOR

Central Study Contacts

Cara Clure, MD

CONTACT

303-724-8482 cara.clure@cuanschutz.edu

Eva Dindinger, MPH

CONTACT

303-724-8482 eva.dindinger@cuanschutz.edu

Study Design

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

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 24, 2022

Study Start

February 20, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing: Will not share

Locations

US(1)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (3)

Study Arms (1)

Mentrual Cup Removal

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (3)

Study Arms (1)

Mentrual Cup Removal

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations