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.
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.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Aude Beloeuvre, MD, 1 58 41 19 08 ext. +33, aude.beloeuvre@aphp.fr
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.
- Conditions
- Primary Immune Deficiency Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Patients | Adult 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.
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)
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.
- First posted25 Jul 2024
- Study start1 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Deficiency DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Caroline Charlier-Woerther, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisAude Beloeuvre, MD, Study director, Assistance Publique - Hôpitaux de ParisNizar Mahlaoui, MD, Study director, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
- ClinicalTrials.gov ID
- NCT06519734
- Acronym / sponsor ID
- FEMIDIP / APHP240435
- Conditions
- Primary Immune Deficiency Diseases
- Keywords
- Primary immune deficiency diseases, Contraception, Intrauterine device, Menstrual hygiene products, Menstrual cups, Tampons, Infectious complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Jul 2024 (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.
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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnaireAdult women registered in the Center for Hereditary Immune Deficits (CEREDIH), hospital Necker-Enfants Malades, Paris. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with primary immune deficiency disease included in the CEREDIH (reference Center for Hereditary Immune Deficits) national cohort.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Refusal to participate of the study
- Deceased patient
- Minor patient
- Patient under legal protection
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 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. | Other | Patients |
Primary outcome
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
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.
1 secondary outcome
Frequency of use of intrauterine devices, menstrual cups and tampons in patients with primary immunodeficiency
Time frame: Time 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Caroline Charlier-Woerther, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Aude Beloeuvre, MD study director
Assistance Publique - Hôpitaux de Paris
Nizar Mahlaoui, MD study director
Assistance Publique - Hôpitaux de Paris
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 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.