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Menstrual Cup Removal for IUD Complications

N/A

Recruiting

Led By Cara Clure, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Between the ages of 18-45

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-18 months

Awards & highlights

Study Summary

This trial will study if and how menstrual cups may cause IUDs to be displaced. The investigator hypothesizes that breaking the seal when inserting or removing the cup will result in a 15% rate of IUD displacement/expulsion.

Who is the study for?

This trial is for women aged 18-45 who currently have an FDA-approved IUD and are visiting CWHC for IUD removal. They cannot participate if they have a vaginal infection, can't see their IUD strings, are pregnant, or allergic to silicone.Check my eligibility

What is being tested?

The study is testing whether removing menstrual cups in the way manufacturers recommend (by breaking the seal) affects the position of an intrauterine device (IUD). The goal is to understand if suction contributes to IUD displacement.See study design

What are the potential side effects?

There may not be direct side effects from participating in this study since it involves standard menstrual cup use. However, there's a potential risk that the process could displace an IUD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am female.

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I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hip Dislocation

Secondary outcome measures

The rate of IUD displacement measured by the frequency of IUDs that shift >1cm after manufacturer-recommended menstrual cup insertion and removal followed by insertion and removal the menstrual cup without breaking the seal.

Other outcome measures

III. The proportion of subjects who report feeling suction during menstrual cup removal.

III. The proportion of subjects who report palpating the IUD strings during menstrual cup removal.

III. The proportion of subjects who report pulling on the menstrual cup stem before breaking the seal.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mentrual Cup RemovalExperimental Treatment1 Intervention

Menstrual Cup Removal.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,746 Previous Clinical Trials

2,164,040 Total Patients Enrolled

Cara Clure, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

75 Total Patients Enrolled

Media Library

Mentrual Cup Removal Clinical Trial Eligibility Overview. Trial Name: NCT05254041 — N/A

Menstrual Cup Research Study Groups: Mentrual Cup Removal

Menstrual Cup Clinical Trial 2023: Mentrual Cup Removal Highlights & Side Effects. Trial Name: NCT05254041 — N/A

Mentrual Cup Removal 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254041 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity of this clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov suggests that this medical research, which was initially published on February 20th 2022, is still recruiting patients. 80 participants are needed to be enrolled at 1 site."

Answered by AI

Are those aged fifty and above being included in the experimental protocol?

"According to the eligibility guidelines, participants must be 18 years in age or above, and not exceed 45."

Answered by AI

Is this research project currently looking for participants?

"That is correct. Clinicaltrials.gov's records show that this medical experiment, which first launched on February 20th 2022, is still looking for participants. 80 people are needed from 1 distinct site to complete the trial's objectives."

Answered by AI

Are there any particular types of individuals who are better suited to take part in this scientific experiment?

"This research requires 80 volunteers who use a menstrual cup, aged 18 to 45. The primary selection criteria are: Female gender, possessing an FDA-approved IUD, undergoing removal at CWHC and fitting the age range of 18-45 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05254041.