Меню
Набор скоро начнётся NCT07391917

Human Seminal Plasma Allergy: Quality of Life

— Наблюдательное Allergic Reaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Allergic Reaction. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

ALExSEM - Hypersensibilité au Liquide séminal : Qualité de Vie ALExSEM - Human Seminal Plasma Allergy: Quality of Life

Обзор

Human Seminal Plasma Allergy (HSPA) is a rare allergy with localized and/or generalized manifestations following exposure during unprotected sex. Its cause remains undetermined and is certainly underdiagnosed. It is an under-recognized cause of acute or chronic pain related to penetration and vaginal inflammation affecting sexually active women. To date, no quality-of-life questionnaire specific to this condition exists to demonstrate its impact on the physical, mental, and sexual health of patients. To try to highlight the suffering of these patients, non-specific sexual quality-of-life questionnaires exist and could be used, such as the "Female Sexual Function Index" (including questions on desire, arousal, and the ability to reach orgasm), but these do not address the sexual impact of psychological distress related to any pathology and do not assess the impact of HSPA-specific symptoms on sexuality. The symptoms of endometriosis can be compared to those of patients with HSPA due to chronic abdominopelvic pain that worsens during sexual intercourse, the psychological impact, and the potential effect on fertility. A specific questionnaire exists for patients with endometriosis that documents these commonalities: the EHP-30. It is recognized as a specific and sensitive tool for measuring the quality of life of women with endometriosis in routine clinical practice. However, the EHP-30 questionnaire focuses on symptoms that are often chronic and persistent, even outside of sexual intercourse, whereas HSPA is characterized by acute episodes, sometimes spaced out and dependent on exposure to seminal fluid, making the tool less relevant for assessing the quality of life of patients with HSPA. This study aims to evaluate and compare the measurement of quality of life in patients with HSPA using these different tools and a specific general question in order to describe quality of life in this population. This will also provide evidence to question the value of creating a questionnaire specific to the pathology.

Подробное описание

After enrollment and questionnaire collection, relevant medical data are gathered from the medical record (data recorded during the consultation) :

* General data: age, weight/height, number of children, desire for pregnancy, use of assisted reproductive technology, presence of a male dog or cat in the home * Comorbidities at diagnosis: atopic predisposition, allergies, asthma, eczema, urticaria, chronic rheumatological/urological/gynecological/psychiatric/other conditions * Characterization of the seminal fluid allergy: date of diagnosis, symptoms, number of partners with whom symptoms have occurred, time to onset of symptoms after exposure, duration of symptoms, results of allergy testing (prick tests, specific IgE, seminal fluid TB test) * Treatments offered and response (if applicable) * Outcome: Stability, improvement, worsening, recovery

Первичные конечные точки

  • Overall Quality of life (WHOQOL-BREF) [Срок оценки: 1 day]
  • Sexual Quality of life (FSFI) [Срок оценки: 1 day]
  • Quality of life and chronic gynecological condition (EHP30) [Срок оценки: 1 day]
  • Quality of life and HSPA [Срок оценки: 1 day]
Вторичные конечные точки (9)
  • Relationships between the scores [Срок оценки: 1 day]
  • Perception of validated questionnaires used [Срок оценки: 1 day]
  • Population [Срок оценки: 1 day]
  • Risk factors : BMI [Срок оценки: 1 day]
  • Risk factors : age [Срок оценки: 1 day]
  • Risk factors : children [Срок оценки: 1 day]
  • Risk factors : pregnancy [Срок оценки: 1 day]
  • Risk factors : eczema [Срок оценки: 1 day]
  • Risk factors : respiratory [Срок оценки: 1 day]

Критерии участия

Критерии включения

  • Adult patient
  • Treated at Angers University Hospital for Human Seminal Plasma Allergy during the period of interest (2010-2026)

Критерии исключения

  • Objecting to participating in the research

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Sandra MERZEAU — Angers

Идентификаторы

NCT: NCT07391917 · 2025-A02920-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗