Impact of Ehlers-Danlos Syndrome on Gynaecological Health

NCT ID: NCT07151274

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-02-01

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.

Detailed Description

Patients with SED report a high prevalence of gynaecological disorders, including severe dysmenorrhoea, menorrhagia and dyspareunia. Chronic pelvic pain and pelvic floor disorders are also common, impacting quality of life and reproductive function. Menorrhagia is common and may be due to capillary fragility and altered uterine connective tissue. The use of contraceptive hormones is often considered to reduce menstrual symptoms, although their effectiveness varies. A multidisciplinary approach is recommended to tailor treatments to the specific needs of patients.

Epidemiological data on the prevalence of EDS and hypermobility spectrum disorder show an increase in diagnoses, highlighting the importance of better clinical recognition.

Primary dysmenorrhoea is generally linked to excessive production of prostaglandins, leading to uterine hypercontractility and transient myometrial ischaemia. In patients with EDS, several pathophysiological mechanisms could contribute to exacerbated menstrual pain:

• Collagen dysregulation: fragility of uterine connective tissues that can alter myometrial contractility.
• Frequent dysautonomia in SED: may alter uterine vascularisation and amplify pain.
• Nociceptive hypersensitivity: described in patients with SED, increasing pain perception. This project hypothesises that patients with EDS experience more severe and/or more frequent dysmenorrhoea than the general population due to the tissue and neurological alterations specific to this syndrome.

Thus, evidence of increased dysmenorrhoea severity in EDS patients could justify better pain management and gynaecological care for these patients.

Better recognition of gynaecological disorders in EDS could prevent late diagnoses and therapeutic uncertainty.

Better recognition of gynaecological disorders in EDS could help to avoid late diagnoses and therapeutic uncertainty.

The prospects for this research are to show that a significant difference could be observed and to explore the underlying mechanisms (dysautonomia, local inflammation, myometrial abnormalities) in greater depth. The benefits of specialised gynaecological care with the introduction of hormone therapy could also be explored.

Conditions

Ehlers-Danlos Syndrome (EDS)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Minors (< 18 years old).
• Menopausal women
• People who do not understand French well enough to complete the questionnaire.
• Uncertain diagnosis of EDS (exclusion of participants who suspect EDS but without medical confirmation).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Mathilde ML LECOINTRE, Doctor

Role: CONTACT

melodie.lecointre@chu-rouen.fr

02 32 88 07 89 ext. +33

Constance CB BOHN, Doctor

Role: CONTACT

constance.bohn@chu-rouen.fr

02 32 88 07 89 ext. +33

Other Identifiers

2025-A00962-47

Identifier Type: OTHER

Identifier Source: secondary_id

2025/0124/OB

Identifier Type: -

Identifier Source: org_study_id