ALExSEM - Hypersensibilité au Liquide séminal : Qualité de Vie ALExSEM - Human Seminal Plasma Allergy: Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Quality of life (WHOQOL-BREF)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Treated at Angers University Hospital for Human Seminal Plasma Allergy during the period of interest (2010-2026)
排除标准
- •Objecting to participating in the research
研究组 & 干预措施
women with HSPA
Measure of quality of life with different questionnaires
结局指标
主要结局
Overall Quality of life (WHOQOL-BREF)
时间窗: 1 day
Measure of overall and domain-specific quality of life using the WHOQOL-BREF questionnaire (26 items). Unit of measurement: quality of life scores (overall score and scores for the 4 domains: physical health, psychological health, social relationships, environment), calculated from items rated on a Likert-type scale and converted into continuous scores (items scores between 4 and 20 ; higher scores = better quality of life).
Sexual Quality of life (FSFI)
时间窗: 1 day
Measure of sexual quality of life using the Female Sexual Function Index (FSFI) questionnaire. Unit of measurement: total FSFI score and scores for individual domains (desire, arousal, lubrication, orgasm, satisfaction, pain), calculated from items rated on a Likert-type scale (higher scores = better sexual function). Total score of 2 to 36.
Quality of life and chronic gynecological condition (EHP30)
时间窗: 1 day
Measure of the impact of endometriosis on quality of life using the Endometriosis Health Profile 30 (EHP 30) questionnaire as a reference for the chronic gynecological condition HSPA Unit of measurement: scores for domains (including pain, control and power, emotional well-being, social relationships, and work life), expressed on a scale of 0 to 4. Total score of 0 to 100 (0 = no impact/best quality of life, 100 = maximum impact on quality of life/worst quality of life).
Quality of life and HSPA
时间窗: 1 day
Perceived quality of life related to the HSPA is measured using a general question: "How would you rate your overall quality of life in relation to your HSPA?" Unit of measurement: score on a numerical scale from 0 to 10 (0 = worst quality of life; 10 = perfect quality of life).
次要结局
- Risk factors : eczema(1 day)
- Risk factors : respiratory(1 day)
- Relationships between the scores(1 day)
- Perception of validated questionnaires used(1 day)
- Population(1 day)
- Risk factors : BMI(1 day)
- Risk factors : age(1 day)
- Risk factors : children(1 day)
- Risk factors : pregnancy(1 day)