Human Seminal Plasma Allergy: Quality of Life

NCT07391917 | Not Yet Recruiting

• 1 other identifier: 2025-A02920-49
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergic Reaction

Keywords

seminal fluid; allergy; sexuality; quality of life; Human Seminal Plasma Allergy (HSPA)

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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).

  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).

  1 day

Secondary Outcomes (9)

• 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

Study Arms (1)

women with HSPA

Measure of quality of life with different questionnaires

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Human Seminal Plasma Allergy (HSPA)

You may qualify if:

• Adult patient
• Treated at Angers University Hospital for Human Seminal Plasma Allergy during the period of interest (2010-2026)

You may not qualify if:

• Objecting to participating in the research

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Sandra MERZEAU

Angers, 49933, France

Location

MeSH Terms

Conditions

Hypersensitivity; Sexuality

Condition Hierarchy (Ancestors)

Immune System Diseases; Sexual Behavior; Behavior

Study Officials

• Martine MORISSET, Dr

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine MORISSET, Dr

CONTACT

(0)2 41 35 35 51; mamorisset@chu-angers.fr

Emeline BRUXELLE

CONTACT

(0)2 41 35 35 51; emeline.bruxelle@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 6, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): August 22, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-01

Locations

FR (1)