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NCT Number: NCT07391917

Human Seminal Plasma Allergy: Quality of Life

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.

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Key information

Conditions

Allergic Reaction Behavior Hypersensitivity Immune System Diseases Sexual Behavior Sexuality

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Quality of life (WHOQOL-BREF)

    Time frame: 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).

  2. Sexual Quality of life (FSFI)

    Time frame: 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.

  3. Quality of life and chronic gynecological condition (EHP30)

    Time frame: 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).

  4. Quality of life and HSPA

    Time frame: 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).

Secondary outcomes

  1. Relationships between the scores

    Time frame: 1 day

    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.

  2. Perception of validated questionnaires used

    Time frame: 1 day

    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)

  3. Population

    Time frame: 1 day

    Describe the characteristics of the population treated at the University Hospital of Angers for HSPA

  4. Risk factors : BMI

    Time frame: 1 day

    Current Body Mass Index (BMI): < 20 kg/m²; 20-29 kg/m²; ≥ 30 kg/m²

  5. Risk factors : age

    Time frame: 1 day

    Age: 18-35 years; 35-50 years; > 50 years

  6. Risk factors : children

    Time frame: 1 day

    Number of biological children

  7. Risk factors : pregnancy

    Time frame: 1 day

    Desire for pregnancy

  8. Risk factors : eczema

    Time frame: 1 day

    History of eczema

  9. Risk factors : respiratory

    Time frame: 1 day

    History of respiratory allergies and/or asthma

Study contacts

Contact information is provided by the study sponsor or research team.

Emeline BRUXELLE

CONTACT

[email protected]

(0)2 41 35 35 51 ext. 33

Martine MORISSET, Dr

CONTACT

[email protected]

(0)2 41 35 35 51 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: ALExSEM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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