Allergic ReactionALExSEMNCT07391917
Human Seminal Plasma Allergy: Quality of Life
An observational study of Allergic Reaction, run by University Hospital, Angers at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Allergic Reaction
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2026to 22 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Human Seminal Plasma Allergy (HSPA)
Who may be able to join
- Adult patient
- Treated at Angers University Hospital for Human Seminal Plasma Allergy during the period of interest (2010-2026)
Who cannot join
- Objecting to participating in the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Sandra MERZEAU
Angers, 49933
Martine MORISSET, Dr, (0)2 41 35 35 51 ext. 33, mamorisset@chu-angers.fr
Sandra MERZEAU, PHD, (0)2 41 35 59 70 ext. 33, samerzeau@chu-angers.fr
About this study
Official title: ALExSEM - Hypersensibilité au Liquide séminal : Qualité de Vie ALExSEM - 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.
Read more
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.
Read the 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
- Conditions
- Allergic Reaction
- Keywords
- seminal fluid, allergy, sexuality, quality of life, Human Seminal Plasma Allergy (HSPA)
- Medical subject headings
- Hypersensitivity, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women with HSPA | Measure of quality of life with different questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 1 day
Secondary outcomes (9)
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.
Measured: 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)
Measured: 1 day
Population
Describe the characteristics of the population treated at the University Hospital of Angers for HSPA
Measured: 1 day
Risk factors : BMI
Current Body Mass Index (BMI): < 20 kg/m²; 20-29 kg/m²; ≥ 30 kg/m²
Measured: 1 day
Risk factors : age
Age: 18-35 years; 35-50 years; > 50 years
Measured: 1 day
Risk factors : children
Number of biological children
Measured: 1 day
Risk factors : pregnancy
Desire for pregnancy
Measured: 1 day
Risk factors : eczema
History of eczema
Measured: 1 day
Risk factors : respiratory
History of respiratory allergies and/or asthma
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start23 Feb 2026 (estimated)
- Primary completion22 Aug 2026 (estimated)
- Study completion22 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Martine MORISSET, Dr, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391917
- Sponsor's protocol ID
- 2025-A02920-49
- Acronym
- ALExSEM
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No