Human Seminal Plasma Allergy: Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Allergic Reaction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ALExSEM - Hypersensibilité au Liquide séminal : Qualité de Vie ALExSEM - Human Seminal Plasma Allergy: Quality of Life
Overview
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.
Detailed description
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
Primary outcome measures
- Overall Quality of life (WHOQOL-BREF) [Time frame: 1 day]
- Sexual Quality of life (FSFI) [Time frame: 1 day]
- Quality of life and chronic gynecological condition (EHP30) [Time frame: 1 day]
- Quality of life and HSPA [Time frame: 1 day]
Secondary outcome measures (9)
- Relationships between the scores [Time frame: 1 day]
- Perception of validated questionnaires used [Time frame: 1 day]
- Population [Time frame: 1 day]
- Risk factors : BMI [Time frame: 1 day]
- Risk factors : age [Time frame: 1 day]
- Risk factors : children [Time frame: 1 day]
- Risk factors : pregnancy [Time frame: 1 day]
- Risk factors : eczema [Time frame: 1 day]
- Risk factors : respiratory [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- Adult patient
- Treated at Angers University Hospital for Human Seminal Plasma Allergy during the period of interest (2010-2026)
Exclusion criteria
- Objecting to participating in the research
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Sandra MERZEAU — Angers
Identifiers
NCT: NCT07391917 · 2025-A02920-49