Examining how menstrual cups may affect IUD displacement
Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use
This study is testing if using menstrual cups can cause IUDs to move out of place in women who use both.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT05254041 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the potential impact of using menstrual cups on the displacement of intrauterine devices (IUDs). The researchers hypothesize that the suction created during the insertion and removal of menstrual cups may lead to a 15% rate of IUD expulsion. By analyzing data on IUD displacement and menstrual cup use, the study aims to identify variables associated with this phenomenon. The findings could help healthcare providers offer better guidance to patients regarding the safe use of menstrual cups alongside IUDs.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18-45 who currently have an FDA-approved IUD and are seeking IUD removal.
Not a fit: Patients with known sensitivities to silicone, active vaginal infections, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved counseling for patients using IUDs and menstrual cups, potentially reducing the risk of unintended pregnancies.
How similar studies have performed: While limited data exists on this specific interaction, the study addresses a novel area of inquiry regarding IUD displacement and menstrual cup use.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado
- Comprehensive Women's Health Center — Denver, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Cara Clure, MD — University of Colorado, Denver
- Study coordinator: Cara Clure, MD
- Email: cara.clure@cuanschutz.edu
- Phone: 303-724-8482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.