An observational study in Allergic Reaction, sponsored by University Hospital, Angers. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by University Hospital, Angers · Observational
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.
After enrollment and questionnaire collection, relevant medical data are gathered from the medical record (data recorded during the consultation) :
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 20 is below the median of 166 across 327 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
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Patients with Human Seminal Plasma Allergy (HSPA)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Measure of quality of life with different questionnaires
Overall Quality of life (WHOQOL-BREF)
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).
Time frame: 1 day
Sexual Quality of life (FSFI)
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.
Time frame: 1 day
Quality of life and chronic gynecological condition (EHP30)
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).
Time frame: 1 day
Quality of life and HSPA
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).
Time frame: 1 day
Relationships between the scores
The relationships between the different assessment tools (WHOQOL-BREF, FSFI, sections C to F of the EHP-30, and the general quality of life question) will be explored using Spearman correlations. Correlation coefficients will be visualized as a correlation matrix (corrplot) to identify potential links between the dimensions assessed by the different questionnaires.
Time frame: 1 day
Perception of validated questionnaires used
An assessment of the questionnaire's relevance in evaluating the impact of the pathology on quality of life is included at the end of each questionnaire. Responses to these questions are given on a 4-point Likert scale. * Is the questionnaire relevant and sufficiently specific to the issues related to HSPA? (0 = Not at all relevant to 3 = Very relevant) * Do you feel that certain important dimensions of HSPA are neglected/not addressed? (0 = Strongly disagree to 3 = Strongly agree) * Do you think this questionnaire alone is sufficient to highlight the impact of HSPA on your quality of life? (0 = Strongly disagree to 3 = Strongly agree) * Do you find some questions and/or sub-scores unnecessary? (0 = Strongly disagree to 3 = Strongly agree)
Time frame: 1 day
Population
Describe the characteristics of the population treated at the University Hospital of Angers for HSPA
Time frame: 1 day
Risk factors : BMI
Current Body Mass Index (BMI): \< 20 kg/m²; 20-29 kg/m²; ≥ 30 kg/m²
Time frame: 1 day
Risk factors : age
Age: 18-35 years; 35-50 years; \> 50 years
Time frame: 1 day
Risk factors : children
Number of biological children
Time frame: 1 day
Risk factors : pregnancy
Desire for pregnancy
Time frame: 1 day
Risk factors : eczema
History of eczema
Time frame: 1 day
Risk factors : respiratory
History of respiratory allergies and/or asthma
Time frame: 1 day
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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