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

NCT ID: NCT04782583

Last Updated: 2021-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

740 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-18

Study Completion Date

2021-05-17

Brief Summary

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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.

Detailed Description

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Conditions

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Menstrual Cup Intrauterine Device Migration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CAS

Questionnaire

Intervention Type OTHER

questionnaire for the patients and the volontaire

TEMOIN

Questionnaire

Intervention Type OTHER

questionnaire for the patients and the volontaire

Interventions

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Questionnaire

questionnaire for the patients and the volontaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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cabinet IPSO

Paris, , France

Site Status

Countries

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France

References

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Claire J, Mir S, Dumortier I, Liard R, Yavchitz A, Le Cossec C, Picard H. The use of a menstrual cup as a risk factor for displacement of intrauterine devices: a case-control study. Contracept Reprod Med. 2025 May 6;10(1):33. doi: 10.1186/s40834-025-00366-3.

Reference Type DERIVED
PMID: 40329407 (View on PubMed)

Other Identifiers

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HPD_2019_18

Identifier Type: -

Identifier Source: org_study_id

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