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Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04782583
Acronym
CUP-DIU
Enrollment
740
Registered
2021-03-04
Start date
2020-03-18
Completion date
2021-05-17
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Device Migration, Menstrual Cup

Brief summary

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.

Interventions

OTHERQuestionnaire

questionnaire for the patients and the volontaire

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluating the risk of IUD displacement in patients using menstrual cup1 DAYTransvaginal ultrasounds will be used to monitor the position of the intrauterine device in patients using a menstrual cup.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026