NCT07004959 Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas (E-STEP)

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 64 participants in total. It began in 2024-11-19 with a primary completion date of 2028-03-19.

Brief Summary

Endometriosis is a disease that affects between 6 and 10% of women of childbearing age. It is defined by the presence of endometrial tissue outside the uterine cavity, most often in the ovaries or the peritoneal cavity. The standard treatment for endometriomas is laparoscopic intraperitoneal cystectomy. This treatment has been shown to be associated with a lower rate of recurrence of painful symptoms than simple cyst drainage, and with higher pregnancy rates. Nevertheless, cystectomy can lead to a reduction in ovarian reserve due to the removal of adjacent healthy ovarian tissue, particularly when there is no cleavage plane between the ovary and the endometrioma. Other methods have been developed to manage endometriomas while preserving the ovarian reserve. Endometrioma sclerotherapy is one of the most promising techniques for reducing the risk of recurrence while preserving the ovarian reserve. This technique involves injecting a sclerosing agent into the cystic cavity, which has been drained beforehand, in order to create an abrasion of the cystic epithelium, resulting in inflammation and fibrosis that can lead to the permanent destruction of the cyst. The aim of the study is to conduct a single-centre randomised controlled non-inferiority trial comparing sclerotherapy and intraperitoneal cystectomy for the treatment of endometriomas. The main hypothesis of the study is that sclerotherapy is not inferior to cystectomy in terms of reducing painful symptoms one year after the operation and that it is superior to cystectomy on one or more of the following criteria: preservation of ovarian reserve, operative complications, post-operative pain, patient acceptability/satisfaction. The number of patients to be included will be 64, calculated to demonstrate non-inferiority between sclerotherapy and cystectomy for the primary endpoint.

Eligibility Criteria

Inclusion Criteria: * Patients aged between 18 and 45 * Endometrioma diagnosed by endovaginal ultrasound or MRI (examinations carried out by a radiologist or gynaecologist) with a typical appearance and whose largest diameter is between 3 and 10 centimetres. * Pain (dysmenorrhoea or chronic pelvic pain) with a VAS greater than 30 millimetres, assessed by the question "Indicate the subjective level of your endometriosis-related pain over the last 4 weeks". Exclusion Criteria: * Inability to speak French * Refusal to take part in the study * Risk factors for impaired ovarian reserve: * Ovarian reserve already low (AMH \<1,5ng/ml or Antral follicle count \< 7 on the contralateral ovary * Bilateral or multiple endometriomas (two or more endometriomas greater than 3 centimetres in diameter). * Previous cystectomy * Previous major peritoneal surgery causing adhesions. * Contraindication to sclerotherapy : allergy to ethanol * Contraindications to general anaesthesia * Pregnant women, women in labour and nursing mothers

Contact & Investigator

Frequently Asked Questions

Related Trials