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

RecruitingNAAges 18 Years - 45 YearsFemaleAssistance Publique Hopitaux De Marseille
NCT07004959 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ovaria

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📋 Eligibility rules (as published)
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
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What it tests

  • Vaginal ultrasound-guided ethanol sclerotherapy
  • Laparoscopic cystectomy
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Where

1 site
gynecology department APHM
Marseille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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