Clinical trial Recruiting at 1 site Interventional Ages 18 to 45 Women only

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.

More Ovarian Endometrioma trials

Quick facts

Study typeInterventional
Ages18 Years to 45 Years
SexWomen only
Enrollment64 (estimated)
SponsorAssistance Publique Hopitaux De Marseille
Academic / other
Locations1 site (Marseille, France)
StatusRecruiting
StartedNovember 19, 2024
Main results expectedMarch 19, 2028
Study endsMarch 19, 2028
Registry record updatedJune 4, 2025
Trial IDNCT07004959 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

  • gynecology department APHM
    Marseille, France, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.