Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study (CUP-DIU)

In France, 26% of women of childbearing age use an intrauterine device (IUD) containing copper or levonorgestrel as a method of contraception. Failures of IUD contraception are mainly due to shifting or expulsion of the IUD. The risk factors for expulsion of IUDs most often found in the literature are young age (<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper IUD rather than a levonorgestrel IUD , a history of IUD expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis).

More and more women are turning to menstrual cups (MCs) as a means of periodic protection. But the use of MC has also been mentioned as a risk factor for IUD expulsion (via a suction effect). In May 2013, reports of displacement, rupture, or even expulsion of copper IUDs in CM users were reported to ANSM.

However, few studies have examined the risks associated with the concomitant use of an MC and an IUD. The data are contradictory and insufficient to provide a clear answer to women. Hence the interest in carrying out a larger prospective study to explore the relationship between IUD expulsion and the use of MC.

Study Overview

• Status: Completed
• Conditions: Intrauterine Device Migration; Menstrual Cup
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 740

Contacts and Locations

Study Locations

• France
  • Paris, France, 75003
    • Cabinet IPSO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an intrauterine device for contraception.

Description

Inclusion Criteria:

• Patient aged 18 or over

• Consultant for one of the following reasons:

  • IUD control
  • IUD expulsion
  • Pregnancy on IUD
  • Other reason that required an ultrasound for the IUD
• Consent to participate in the study

Exclusion Criteria:

• Patient benefiting from a legal protection measure

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CAS	Other: Questionnaire; questionnaire for the patients and the volontaire
TEMOIN	Other: Questionnaire; questionnaire for the patients and the volontaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the risk of IUD displacement in patients using menstrual cup	Transvaginal ultrasounds will be used to monitor the position of the intrauterine device in patients using a menstrual cup.	1 DAY

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2020
• Primary Completion (Actual): May 17, 2021
• Study Completion (Actual): May 17, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 20, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies; Foreign-Body Migration; Intrauterine Device Migration
• Other Study ID Numbers: HPD_2019_18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No