Impact of Ehlers-Danlos Syndrome on Gynaecological Health

NCT07151274 | Not Yet Recruiting

• 2 other identifiers: 2025/0124/OB2025-A00962-47
• Study Type: observational
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dysmenorrhea is a common problem in gynaecology, significantly impacting patients' quality of life. Ehlers-Danlos syndrome (EDS) is associated with joint hypermobility, tissue fragility and chronic pain. Some studies suggest an increased prevalence of gynaecological disorders, including dysmenorrhea, in patients with EDS. However, data remain limited and few studies have compared the intensity and characteristics of dysmenorrhea in women with EDS. There is also little data on the prevalence of other gynaecological conditions in women with EDS. This study therefore aims to compare the severity of dysmenorrhea in patients with EDS and a control group in order to better characterise the gynaecological impact of EDS. It will also compare the prevalence of other gynaecological conditions between women with EDS and women without EDS.

Conditions

Ehlers-Danlos Syndrome (EDS)

Keywords

gynaecological disorder; dysmenorrhea; menorrhagia; dyspareunia; endometriosis

Outcome Measures

Primary Outcomes (1)

• Assessment of the severity of dysmenorrhea by Numerical Pain Scale (NPS)

  The main objective of this study is to compare the severity of dysmenorrhea in patients with Ehlers-Danlos syndrome (EDS), all types combined, and a control group of patients without connective tissue disease. This comparison will determine whether EDS is a risk factor for more severe dysmenorrhea. The primary endpoint will be measured using the numerical pain scale (NPS), which assesses pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain"

  Day 1

Secondary Outcomes (10)

• Analysis of clinical factors associated with the severity of dysmenorrhea (Age) using Numerical Pain Scale (NPS)

  Day1

• Analysis of clinical factors associated with the severity of dysmenorrhea (Body Mass Index (BMI)) using Numerical Pain Scale (NPS)

  Day1

• Analysis of clinical factors associated with the severity of dysmenorrhea (age of onset of dysmenorrhea,) using Numerical Pain Scale (NPS)

  Day1

• Analysis of clinical factors associated with the severity of dysmenorrhea (presence of associated menorrhagia) using Numerical Pain Scale (NPS)

  Day1

• Analysis of clinical factors associated with the severity of dysmenorrhea (medical history) using Numerical Pain Scale (NPS)

  Day1

Study Arms (2)

Experimental group: women with Ehlers-Danlos syndrome (EDS)

Women with Ehlers-Danlos syndrome (EDS) of all types diagnosed by a healthcare professional

Comparator group: Women not affected by Ehlers-Danlos syndrome (EDS)

Women without Ehlers-Danlos syndrome (EDS) (control group) from a healthy volunteer base

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women diagnosed with Ehlers-Danlos syndrome (EDS)

You may qualify if:

• Women aged 18 or over.
• Willing to participate voluntarily in the study via an online questionnaire.
• Of childbearing age.
• Reporting a diagnosis of EDS (all types) or not having EDS (control group) and being part of a database of healthy volunteers.

You may not qualify if:

• Minors (\< 18 years old).
• Menopausal women
• People who do not understand French well enough to complete the questionnaire.

Sponsors & Collaborators

• University Hospital, Rouen: lead

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Dysmenorrhea; Menorrhagia; Dyspareunia; Endometriosis

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Mathilde ML LECOINTRE, Doctor

CONTACT

02 32 88 07 89; melodie.lecointre@chu-rouen.fr

Constance CB BOHN, Doctor

CONTACT

02 32 88 07 89; constance.bohn@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share