Vaginal ultrasound-guided ethanol sclerotherapy versus laparoscopic cystectomy for ovarian endometriomas.
Randomised Controlled Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas
This study will test whether vaginal ultrasound-guided ethanol sclerotherapy works as well as laparoscopic cystectomy to treat ovarian endometriomas in symptomatic women aged 18–45.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, France) |
| Trial ID | NCT07004959 on ClinicalTrials.gov |
What this trial studies
This is a non-inferiority interventional comparison of vaginal ultrasound-guided ethanol sclerotherapy and standard laparoscopic cystectomy for ovarian endometriomas. Women meeting age and imaging criteria receive one of the two procedures and are followed over time to compare pain recurrence, pregnancy outcomes, and ovarian reserve measures. Key eligibility includes a single endometrioma 3–10 cm with endometriosis-related pain (VAS >30 mm). The trial is carried out at the gynecology department of Assistance Publique–Hôpitaux de Marseille.
Who should consider this trial
Good fit: Women aged 18–45 with a single ovarian endometrioma 3–10 cm diagnosed by endovaginal ultrasound or MRI and moderate to severe endometriosis-related pain (VAS >30 mm).
Not a fit: Patients with bilateral or multiple endometriomas, prior cystectomy or major peritoneal surgery, low ovarian reserve (AMH <1.5 ng/mL or AFC <7), pregnancy, allergy to ethanol, contraindications to general anaesthesia, or inability to participate in French are unlikely to benefit from the sclerotherapy approach tested here.
Why it matters
Potential benefit: If successful, the less invasive sclerotherapy could control symptoms while better preserving ovarian reserve compared with cystectomy.
How similar studies have performed: Smaller non-randomized studies and case series have suggested sclerotherapy can reduce recurrence and better preserve ovarian reserve, but high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Marseille, France
- gynecology department APHM — Marseille, France, France (Recruiting)
Study contacts
- Principal investigator: Antoine NETTER — Assistance Publique - Hôpitaux de Marseille
- Study coordinator: Claire MORANDO
- Email: claire.morando@ap-hm.fr ; promotion.interne@ap-hm.fr
- Phone: 0491382183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.