Recruiting

Suction with Menstrual Cup

Sponsor:

University of Colorado, Denver

Code:

NCT05254041

Conditions

IUD; Complications, Mechanical

Menstrual Cup

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Menstrual Cup Removal

Study Details

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.

Conditions

IUD; Complications, Mechanical

Menstrual Cup

Study ID

NCT05254041

Start date

Feb 20, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Mentrual Cup Removal

Menstrual Cup Removal.

Interventions

Menstrual Cup Removal

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

Primary outcome measure

  • The rate of IUD displacement with manufacturer-recommended menstrual cup insertion and removal [ Time Frame: 12-18 months ]

Central Contacts and Locations

Central contacts

Cara Clure, MD

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

Eva Dindinger, MPH

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

Locations

Comprehensive Women's Health Center

Recruiting

Denver, Colorado, United States, 80230

Contacts

Eva Dindinger, MPH

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

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-02-12.