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 — OTHERParticipants 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 RemovalMenstrual 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
- Cara Clure, MD303-724-8482
- Eva Dindinger, MPH303-724-8482
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Comprehensive Women's Health Center | Denver | Colorado | 80230 |