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Completed

NCT Number: NCT04782583

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

cabinet IPSO

Paris, 75003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

questionnaire for the patients and the volontaire

Primary outcomes

  1. Evaluating the risk of IUD displacement in patients using menstrual cup

    Time frame: 1 DAY

    Transvaginal ultrasounds will be used to monitor the position of the intrauterine device in patients using a menstrual cup.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: CUP-DIU

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2021
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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