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NCT05254041 · ClinicalTrials.gov registry record · NA
Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use
A NA study of IUD; Complications, Mechanical and Menstrual Cup, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05254041: Recruiting NA study of IUD; Complications, Mechanical and Menstrual Cup, sponsored by University of Colorado, Denver.
NCT05254041 is a NA study of IUD; Complications, Mechanical and Menstrual Cup that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05254041, a NA study of IUD; Complications, Mechanical and Menstrual Cup, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The rate of IUD displacement measured by the frequency of IUDs that shift \>1cm after manufacturer-recommended menstrual cup insertion and removal.
Conditions Studied
Interventions
- OTHER Menstrual Cup Removal
Study Locations (1)
Colorado
- Comprehensive Women's Health Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-02-20 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05254041 shows while recruiting
NCT05254041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with IUD; Complications, Mechanical appearing as the primary indexed condition, and to 1 intervention - of which Menstrual Cup Removal is the first listed.
NCT05254041 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05254041 about?
NCT05254041 is a clinical study titled "Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use". 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 ...
What is the current status of trial NCT05254041?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-02-20. Estimated completion is 2026-12-31.
What conditions does trial NCT05254041 study?
This clinical trial studies the following conditions: IUD; Complications, Mechanical, Menstrual Cup.
What interventions are being tested in trial NCT05254041?
The interventions under investigation include: Menstrual Cup Removal (OTHER).
Who is sponsoring clinical trial NCT05254041?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05254041 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05254041's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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