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Primary Immune Deficiency DiseasesFEMIDIPNCT06519734

Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products

An observational study of Primary Immune Deficiency Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Primary immune deficiency diseases (PIDDs) constitute a large group of genetic disorders of the immune system which associates to varying degrees an increased susceptibility to infections and immuno-pathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, malignancy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Primary Immune Deficiency Diseases
What is being tested?
Questionnaire
How many people
200 participants
Where
1 siteFrance
Study dates
1 Jun 2026to Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Female patients with primary immune deficiency disease included in the CEREDIH (reference Center for Hereditary Immune Deficits) national cohort.

Who may be able to join

  • Adult woman with primary immune deficiency disease and registered in the reference Center for Hereditary Immune Deficits (CEREDIH, hospital Necker-Enfants Malades, Paris)
  • Patient not opposed to participation in research

Who cannot join

  • Refusal to participate of the study
  • Deceased patient
  • Minor patient
  • Patient under legal protection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Caroline Charlier-Woerther, MD, PhD contact

1 58 41 19 08 ext. +33

caroline.charlier@aphp.fr

Hélène Morel contact

1 71 19 63 46

helene.morel@aphp.fr

France1 site, 1 recruiting
  • Hôpital Necker-Enfants Malades

    Paris, 75015

    Aude Beloeuvre, MD, 1 58 41 19 08 ext. +33, aude.beloeuvre@aphp.fr

    Recruiting

Other trials in France

About this study

Primary immune deficiency diseases (PIDDs) constitute a large group of genetic disorders of the immune system which associates to varying degrees an increased susceptibility to infections and immuno-pathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, malignancy.

Although their prevalence remains underestimated, there has been an increase in cases diagnosed in the last 10 years. The national average prevalence is 8.6 patients per 100,000 inhabitants with an incidence of 400 new cases per year in France. Life expectancy varies depending on the type of deficiency, and its impact in terms of infectious complications or malignancy.

Read more

With therapeutic progress, life expectancy increases, and more patients are concerned by contraception and menstrual hygiene. Due to the lack of data and for fear of an infectious complication, the use of intrauterine devices (IUD) and tampons or menstrual cups is traditionally advised against in patients with PID.

The objective of the research is to study the contraception methods and menstrual hygiene products used by patients with primary immunodeficiency and to evaluate related infectious complications.

The contraceptive methods of these patients, the occurrence of upper genital infections associated with the use of an intrauterine device, the severity and the evolution of these infections will be evaluated. A possible refusal to insert an intrauterine device by a healthcare professional due to primary immunodeficiency will also be studied.

Likewise, the types of menstrual hygiene products used will be studied - napkins, menstrual cups, tampons, menstrual panties -, as well as the possible occurrence of associated infectious complications - in particular menstrual toxic shock syndrome, and the treatment, severity and evolution of these complications.

Read the detailed description

Primary immune deficiency diseases (PIDDs) constitute a large group of genetic disorders of the immune system which associate to varying degrees an increased susceptibility to infections and immuno-pathological manifestations: allergy, inflammation, autoimmunity, lymphoproliferation, malignancy.

Although their prevalence remains underestimated, there has been an increase in cases diagnosed in the last 10 years. The national average prevalence is 8.6 patients per 100,000 inhabitants and the incidence is 400 new cases per year in France. Life expectancy varies depending on the type of deficiency, and its impact in terms of infectious complications or malignancy.

With therapeutic progress, life expectancy increases and more patients are concerned by contraception and menstrual hygiene. Due to the lack of data and for fear of an infectious complication, the use of intrauterine devices (IUD) and tampons or menstrual cups is traditionally not recommended in patients with PID.

IUDs are one of the most effective, long-lasting and low-cost methods of contraception, which have the major advantage of causing few drug interactions. Access to effective and appropriate contraception is a major issue for patients with PID because these patients have high-risk pregnancies. Multidisciplinary pregnancy planning allows for adaptation of anti-infective treatments and prophylaxis. These patients often have medication that may interfere with oral contraception, so IUDs could provide many benefits. The incidence of upper genital infections after insertion of an IUD in the general population is 1.6 cases per 1000 patient-years, with a risk 6 times higher in the 20 days after insertion. The risk of developing an upper genital infection is linked to the breakdown of the cervical mucus barrier and the introduction of bacteria from the lower genital tract into the uterine cavity.

The main infectious complication associated with the use of intravaginal menstrual protection is menstrual toxic shock syndrome, a rare but serious pathology caused by the production of the TSST-1 toxin by Staphylococcus aureus. The use of a tampon is one of the main risk factors identified and menstrual cups do not seem to be less likely to promote menstrual toxic shock syndrome. These risks lead to the use of tampons and menstrual cups being discouraged in patients with PID. However, there are no data in the literature on the association between immunosuppression and increased risk of menstrual toxic shock syndrome. Additionally, adult patients with PID will likely use these menstrual hygiene products during their lifetime.

It is therefore crucial to better characterize the risks incurred by patients with PID and the potential infectious complications associated with these devices.

The objective of the research is to study the contraception methods and menstrual hygiene products used by patients with primary immunodeficiency and to evaluate related infectious complications.

The contraceptive methods of these patients, the occurrence of upper genital infections associated with the use of an intrauterine device, the severity and the evolution of these infections will be evaluated. A possible refusal to insert an intrauterine device by a healthcare professional due to primary immunodeficiency will also be studied.

Likewise, the types of menstrual hygiene products used will be studied - napkins, menstrual cups, tampons, menstrual panties -, as well as the possible occurrence of associated infectious complications - in particular menstrual toxic shock, and the treatment, the severity and the evolution of these complications.

Being tested
Questionnaire
Keywords
Primary immune deficiency diseases, Contraception, Intrauterine device, Menstrual hygiene products, Menstrual cups, Tampons, Infectious complications
Medical subject headings
Primary Immunodeficiency Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Questionnaire intended for patients on contraceptive modalities and use of menstrual hygiene products.

    Consultation of the medical records of patients who have reported infectious complications linked to the use of intrauterine devices, tampons or menstrual cups.

Study groups in NCT06519734
Study groupRoleWhat they receive
PatientsAdult women registered in the Center for Hereditary Immune Deficits (CEREDIH), hospital Necker-Enfants Malades, Paris.
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of infectious complications associated with the use of intrauterine devices and tampons or menstrual cups in patients with primary immunodeficiency

    Occurrence of an infectious complication - upper genital infection or menstrual toxic shock - associated with the use of an intrauterine device, tampon or menstrual cup in patients with primary immunodeficiency.

    These complications will be declared by patients via the study questionnaire and then confirmed by consultation of the medical file.

    Measured: Time 0

Secondary outcomes (1)
  1. Frequency of use of intrauterine devices, menstrual cups and tampons in patients with primary immunodeficiency

    Frequency of use of intrauterine devices, menstrual cups or tampons reported by patients on the study questionnaire.

    Measured: Time 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start1 Jun 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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 only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06519734
Sponsor's protocol ID
APHP240435
Other IDs
2024-A00635-42
Acronym
FEMIDIP
Status last verified
Oct 2026
First submitted
19 Jul 2024
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Immune Deficiency Diseases, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caroline Charlier-Woerther, MD, PhD (1 58 41 19 08 ext. +33, caroline.charlier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of infectious complications associated with the use of intrauterine devices and tampons or menstrual cups in patients with primary immunodeficiency (time frame: Time 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Oct 2026.

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