Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products

NCT06519734 | Recruiting

• 2 other identifiers: APHP2404352024-A00635-42
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Immune Deficiency Diseases

Keywords

Primary immune deficiency diseases; Contraception; Intrauterine device; Menstrual hygiene products; Menstrual cups; Tampons; Infectious complications

Outcome Measures

Primary Outcomes (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.

  Time 0

Secondary Outcomes (1)

• Frequency of use of intrauterine devices, menstrual cups and tampons in patients with primary immunodeficiency

  Time 0

Study Arms (1)

Patients

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

Other: Questionnaire

Interventions

Questionnaire 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.

Patients

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

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 Officials

• Caroline Charlier-Woerther, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Aude Beloeuvre, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Nizar Mahlaoui, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Caroline Charlier-Woerther, MD, PhD

CONTACT

1 58 41 19 08; caroline.charlier@aphp.fr

Hélène Morel

CONTACT

1 71 19 63 46; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)