Vaginal ultrasound-guided ethanol sclerotherapy versus laparoscopic cystectomy for ovarian endometriomas.
Official title: Randomised Controlled Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas
Run by Assistance Publique Hopitaux De Marseille · NCT07004959 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 64 (estimated) |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, France) |
| Status | Recruiting |
| Started | November 19, 2024 |
| Main results expected | March 19, 2028 |
| Study ends | March 19, 2028 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT07004959 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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).
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
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This trial will see if different surgical methods for treating endometriomas help women who want to get pregnant have higher pregnancy and birth rates and fewer complications.
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Ethanol sclerotherapy for treating ovarian endometriomas
This study tests if a treatment using ultrasound-guided ethanol can help women with painful ovarian cysts shrink them and reduce their symptoms.
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Alcohol sclerotherapy for pelvic pain and quality of life in ovarian endometrioma
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.