Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products

NCT ID: NCT06519734

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-04-30

Brief 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.

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.

Conditions

Primary Immune Deficiency Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Adult women registered in the Center for Hereditary Immune Deficits (CEREDIH), hospital Necker-Enfants Malades, Paris.

Questionnaire

Intervention Type: OTHER

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.

Interventions

Questionnaire

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Charlier-Woerther, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Aude Beloeuvre, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Nizar Mahlaoui, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

Central Contacts

Caroline Charlier-Woerther, MD, PhD

Role: CONTACT

caroline.charlier@aphp.fr

1 58 41 19 08 ext. +33

Hélène Morel

Role: CONTACT

helene.morel@aphp.fr

1 71 19 63 46

Facility Contacts

Aude Beloeuvre, MD

Role: primary

aude.beloeuvre@aphp.fr

1 58 41 19 08 ext. +33

Other Identifiers

2024-A00635-42

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240435

Identifier Type: -

Identifier Source: org_study_id