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

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05254041
Status
Recruiting

Conditions

  • IUD; Complications, Mechanical
  • Menstrual Cup

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Menstrual Cup Removal — OTHER
    Participants will be asked to remove Menstrual cup by breaking the seal.

Study Details

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.

Key Dates

Start date
Feb 20, 2022
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Mentrual Cup Removal
    Menstrual Cup Removal.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Women's Health CenterDenverColorado80230
Eva Dindinger, MPH
303-724-8482

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