Whole-Body Cryotherapy to Help Endometriosis Pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site, single-arm pilot study will enroll up to 30 participants with symptomatic endometriosis and chronic pelvic pain for more than six months. Over about 12 months, participants will complete two hospital visits about four weeks apart and receive five WBCT sessions (about 3 minutes each) in a -120°C chamber between visits. The study will measure changes in systemic inflammation and other biological markers using blood, saliva, urine, vaginal, and stool samples, alongside patient-reported outcomes. It aims to assess feasibility, safety, acceptability, and preliminary efficacy of WBCT for endometriosis-related pain and quality of life, while exploring potential mechanisms of action.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women or assigned female at birth
* Aged 16 or over
* Endometriosis identified at laparoscopy or imaging, performed within the last ten years
* Chronic pelvic pain for more than six months
* Willing to comply with the treatment
* Willing to use effective contraception throughout the trial (if needed)
* Willing and able to give informed consent

Exclusion Criteria:

* Pregnant, breastfeeding or actively trying to get pregnant
* Post-menopausal (no periods for \>12 months and not taking hormonal treatments to prevent periods, or bilateral oophorectomy performed)
* Previous hysterectomy with bilateral oophorectomy
* Raynaud's Disease
* Current treatment for malignancy
* Diabetes
* Known hypothyroidism
* Pre-existing or current diagnosis of anaemia
* Cardiovascular disease: severe hypertension (180/100, unstable angina, arrhythmia, recent (\<6months) myocardial infarction, peripheral artery disease, cardiac pacemaker, recent (\<6months) stroke or transient ischaemic attack)
* Acute kidney and urinary tract diseases
* Cryoglobulinemia
* Previous venous thromboembolism or peripheral artery occlusive disease
* Cold urticaria
* Livedo reticularis
* Open wounds or ulcers, large-area bacterial and viral skin infections
* Uncontrolled seizure disorder
* Known coagulopathy (eg von Willibrand disease, haemophilia)
* Severe claustrophobia
* Acute infections and fever
* Intoxication (alcohol, drugs)
* Signs or symptoms of cold allergy
* Severe wasting diseases
* Known Hepatitis B/C and/or HIV (due to Royal Mail restrictions on biospecimen postage)

Where it's running

• Institute for Regeneration and Repair, University of Edinburgh and Royal Infirmary of Edinburgh
  Edinburgh, Scotland, United Kingdom Recruiting

Similar studies

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• Atypical Endometriosis: Histology, Immunophenotype and Molecular Features

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.