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NCT Number: NCT07151274

Impact of Ehlers-Danlos Syndrome on Gynaecological Health

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Primary outcomes

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

    Time frame: Day 1

    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"

Secondary outcomes

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

    Time frame: Day1

    Examine the impact of age on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain."

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

    Time frame: Day1

    Examine the impact of BMI on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain."

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

    Time frame: Day1

    Examine the impact of age of onset of dysmenorrhea, on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain."

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

    Time frame: Day1

    Examine the impact of presence of associated menorrhagia on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain.".

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

    Time frame: Day1

    Examine the impact of medical history on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain."

  6. Study of the prevalence of gynaecological conditions (menorrhagia)

    Time frame: Day 1

    Evaluate the frequency of occurrence of a menorrhagia

  7. Study of the prevalence of gynaecological conditions (endometriosis)

    Time frame: Day 1

    Evaluate the frequency of occurrence of endometriosis

  8. Study of the prevalence of gynaecological conditions (adenomyosis)

    Time frame: Day 1

    Evaluate the frequency of occurrence of a adenomyosis

  9. Study of the prevalence of gynaecological conditions (PolyCystic ovary syndrome (PCOS))

    Time frame: Day 1

    Evaluate the frequency of occurrence of PCOS

  10. Study of the prevalence of gynaecological conditions (abnormal cervical smear)

    Time frame: Day 1

    Evaluate the frequency of occurrence of abnormal cervical smear

Study contacts

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

Constance CB BOHN, Doctor

CONTACT

[email protected]

02 32 88 07 89 ext. +33

Mathilde ML LECOINTRE, Doctor

CONTACT

[email protected]

02 32 88 07 89 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Impact of Ehlers-Danlos Syndrome on Gynaecological Health: Focus on the Prevalence of Dysmenorrhoea

Acronym: GYNESED

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Jun 10, 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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