Menstrual CupCUP-DIUNCT04782583
Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study
An observational study of Menstrual Cup and Intrauterine Device Migration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Menstrual Cup, Intrauterine Device Migration
- What is being tested?
- Questionnaire
- How many people
- 740 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2020to 17 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an intrauterine device for contraception.
Who may be able to join
- 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
Who cannot join
- Patient benefiting from a legal protection measure
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Menstrual Cup, Intrauterine Device Migration
- Being tested
- Questionnaire
- Medical subject headings
- Intrauterine Device Migration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
questionnaire for the patients and the volontaire
| Study group | Role | What they receive |
|---|---|---|
| CAS | Not described Receives: Other: Questionnaire | |
| TEMOIN | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start18 Mar 2020
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual CupStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782583
- Sponsor's protocol ID
- HPD_2019_18
- Acronym
- CUP-DIU
- Status last verified
- Jun 2021
- First submitted
- 13 Jan 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40329407
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study
- ClinicalTrials.gov ID
- NCT04782583
- Acronym / sponsor ID
- CUP-DIU / HPD_2019_18
- Conditions
- Menstrual Cup, Intrauterine Device Migration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAS | – | Other: Questionnaire |
| TEMOIN | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an intrauterine device for contraception.
Key inclusion criteria (7 listed)
- Patient aged 18 or over
- Consultant for one of the following reasons:
- Consent to participate in the study
Key exclusion criteria (1 listed)
- Patient benefiting from a legal protection measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairequestionnaire for the patients and the volontaire | Other | CAS, TEMOIN |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 40329407Claire 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cup and Intrauterine Device Migration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the risk of IUD displacement in patients using menstrual cup (time frame: 1 DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.