NCT05254041 Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use
| NCT ID | NCT05254041 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | IUD; Complications, Mechanical |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-02-20 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-02-20 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Cara Clure, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05254041 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying IUD; Complications, Mechanical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05254041 currently recruiting?
Yes, NCT05254041 is actively recruiting participants. Contact the research team at cara.clure@cuanschutz.edu for enrollment information.
Where is the NCT05254041 trial being conducted?
This trial is being conducted at Denver, United States.
Who is sponsoring the NCT05254041 clinical trial?
NCT05254041 is sponsored by University of Colorado, Denver. The principal investigator is Cara Clure, MD at University of Colorado, Denver. The trial plans to enroll 80 participants.