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

NCT04782583 | Completed

• 1 other identifier: HPD_2019_18
• Study Type: observational
• Target: 740
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Cup; Intrauterine Device Migration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CAS

Other: Questionnaire

TEMOIN

Other: Questionnaire

Interventions

Questionnaire OTHER

questionnaire for the patients and the volontaire

CAS; TEMOIN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an intrauterine device for contraception.

You may qualify if:

• 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

You may not qualify if:

• Patient benefiting from a legal protection measure

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

cabinet IPSO

Paris, 75003, France

Location

Related Publications (1)

• 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.

  PMID: 40329407 DERIVED

MeSH Terms

Conditions

Intrauterine Device Migration

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Foreign-Body Migration; Foreign Bodies; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: March 4, 2021
• Study Start: March 18, 2020
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

FR (1)